Medical device safety information

Medical Devices

The manufacturer or authorised representative of the manufacturer of a medical device must notify the Agency for Medicinal Products and Medical Devices in writing of any corrective action it intends to carry out in order to reduce as far as possible the possibility of a recurrence of an adverse incident concerning the medical device.

In addition to notifying the Agency, the manufacturer or authorised representative of the manufacturer of a medical device must notify users about the corrective action by providing safety information using a method that guarantees that all users are notified. The safety information should be in Croatian language and include the elements set out in Annex III of the Ordinance on Monitoring Adverse Incidents Related to Medical Devices (Official Gazette, no. 125/13).

We present received safety information notifications below.

Information about the volontary recall of the stomach tube CH 18 medical device lot

26.07.2012

Medicina trgovina d.o.o., the holder of the registry enrollment of the medical device has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) decided to urgently recall one lot of the stomach tube CH 18 medical device of the manufacturer Changshu Taining Medical Equipment Co. Ltd, China due to a suspected product quality defect. The LOT 20100120 is being recalled by this decision.

On 26 July 2012, HALMED received a report from a health care facility about an unopened, sterile packaging of the aforementioned product in which, through a protective folio, a strange body that may possibly cause a contamination of the product, was observed. Therefore, HALMED informed the holder of the enrollment registry, who from precautions decidet to recall the aformentioned lot.

In the Republic of Croatia has not been reported any adverse event associated with the described problem with the stomach tube CH 18 medical device.

Volontary withrawal of certain batches of the medical device IMAGER II angiographic catheter

26.04.2012

Medical Intertrade d.o.o., the registration holder of this medical device in Croatia, has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the volontary withrawal of certain batches of medical devices IMAGER II angiographic catheter, manufactured by Boston Scientific Corporation, USA, due to a detected quality defects in certain product batches.

Boston Scientific Corporation, USA, the manufacturer , has received reclamations about defective packagings, resulted from physical interactions between the carton on the pouch where the hub is located which may cause contamination of the product. Therefore, the manufacturer has taken precautions measures and decided to withraw all the affected batches.

Changes in the use of Macrolane medical device – discontinuation of the indication for breast enhancement

20.04.2012

Q-Med, the manufacturer has decided to discontinue the promotion of Macrolane for breast enhancement as it may interefere with the reading of mammograms. In those cases, additional ultrasound examinations are needed. Macrolane may sometimes in certain cases cause harmless lumps in brest, which results with unnecessary examinations and patient anxiety.

Macrolane is a non-permanent gel consisting of stabilised hyaluronic acid and it is intended for temporary augmentation, volume restauration and body contour shaping. The promotion of Macrolane is being discontinued for breast enhancement only due to the interference in radiology diagnostics. Macrolane is a safe product with regard to the fact that hyaluronic acid is a natural component of human tissues and is in certain time period degradable by natural processes.

Macrolana may be further on promoted for volume augmentation of other body surface parts, i.e. buttocks, calfs, breast in men etc., as well as for restauration and shaping of dammaged body contours, caused by soft tissue difects, i.e. lipoatrophy.

In Croatia, Macrolane is not widely used and it is implanted in only two patients, who will be informed by their doctors about the change in the use of this product. Proximun d.o.o., the registration holder has committed himself to inform all the users about this change. The change in the use of macrolane medical device will be included in the information leaflet and labelling of this product.