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

Model Number 5X7 CM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rheumatoid Arthritis (1724); Swelling (2091)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

Device is already degraded.

Event Description

Patient had a swelling in the area of the implanted vivosorb.Surgery date: (b)(6) 2016.After ca 2 months problems occurred (swelling of the ventral side wrist at the height of the scar).Reintervention performed on (b)(6) 2016.Patient suffered from serious ra (rheumatoid arthritis), and had several surgeries before (tenosynovectomy, tendon reconstruction, arthroplasty).Tissue will be sent to lab for analysis on granulocytes, mast and giant cells.

• 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; rozenburglaan 15a; groningen, 9727D L; NL 9727DL
• Manufacturer Contact: betty ijmker ; rozenburglaan 15a; groningen, 9727 -DL ; NL 9727 DL ; 05886598
• MDR Report Key: 6201988
• MDR Text Key: 63187963
• Report Number: 3004504732-2016-00002
• 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: 12/23/2016

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: Physician
• Device Model Number: 5X7 CM
• Device Catalogue Number: FS01-035/20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 70 YR