MAUDE Adverse Event Report: POLYGANICS INNOVATIONS BV VIVOSORB; SURGICAL MESH

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Reaction (2414)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

The product was not received for further information and no information was received on the lot number, expiry date, device storage etc.Foreign body responses or infections may occur with the use of implantable devices, which are known complications.It is included in the manufacturer's instructions for use as a possible adverse event.

Event Description

Initial information: the patient showed a major reaction around the median nerve (at the height of the wrist) after 6 weeks.Foreign body giant cell reaction, according to the surgeon caused by vivosorb.Second information (conclusion surgeon): chronic mild active inflammation with a histiocytic reaction, probably due to foreign body material.No other specifics.Final information: patient was treated for a rcurring carpal tunnel syndrome (cts) to prevent new adhesions.Surgeon indicated: it appear to be foreign bidy giant cell reaction.Patient is familiar with several allergies.Outcome patient: the hand is much calmer and the patient is recovering.(this event was already reported, but only the follow-up report had been received).

• Brand Name: VIVOSORB
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): POLYGANICS INNOVATIONS BV; rozenburglaan 15a; groningen, 9727D L; NL 9727DL
• Manufacturer (Section G): POLYGANICS INNOVATIONS BV; rozenburglaan 15a; groningen, 9727 DL; NL 9727 DL
• Manufacturer Contact: betty ijmker ; rozenburglaan 15a; groningen, 9727 -DL ; NL 9727 DL
• MDR Report Key: 6201989
• MDR Text Key: 212290443
• Report Number: 3004504732-2016-00001
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K042811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female