MAUDE Adverse Event Report: GENZYME BIOSURGERY (SEPRAMESH) SEPRAMESH; MCN

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

Patient Problems Emotional Changes (1831); Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

Suffered permanent injuries [injury nos] emotional distress [emotional distress] significant pain and suffering [pain] diminished quality of life [general physical health deterioration] case narrative: initial information from united states received on 14-jan-2021 regarding an unsolicited valid serious case received from a lawyer (legal case).This case involves adult patient who experienced emotional distress, significant pain and suffering, suffered permanent injuries and diminished quality of life, with the use of medical device carboxymethylcellulose, polypropylene, sodium hyaluronate (sepramesh).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using carboxymethylcellulose, polypropylene, sodium hyaluronate at unknown dose, frequency via unknown route (lot - unk) for unknown indication.On an unknown date after an unknown latency patient developed emotional distress, significant pain and suffering (pain), permanent injuries (injury), diminished quality of life (general physical health deterioration) and lost wages and earning capacity.Action taken: not applicable for all events it was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for all events a product technical complaint was initiated and the results for the same were pending.

• Brand Name: SEPRAMESH
• Type of Device: MCN
• Manufacturer (Section D): GENZYME BIOSURGERY (SEPRAMESH); 76 new york avenue; framingham 01701
• Manufacturer (Section G): GENZYME BIOSURGERY (SEPRAMESH); 76 new york avenue; framingham 01701
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 11206740
• MDR Text Key: 227921322
• Report Number: 1221601-2021-00001
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability