MAUDE Adverse Event Report: GENZYME BIOSURGERY (SEPRAFILM/PACK) SEPRAFILM; MCN

Model Number 5959680

Device Problem Defective Device (2588)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 11/08/2012

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 31-aug-2018: this case concerns a female patient who received treatment with seprafilm and later underwent surgeries due to mesh-related complications and also had permanent disability and serious injury due to physical pain.The relationship of the event with suspect cannot be denied.However, further information regarding patient¿s current clinical presentation, onset latencies and other risk factors precludes the complete medical case assessment.

Event Description

Mesh-related complications [complication associated with device] ([device defective]) physical pain [pain].Case narrative: initial information received on 15-aug-2018 regarding an unsolicited valid serious case received from a lawyer.This case involves adult female patient who experienced mesh-related complications and physical pain, while she was using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The reported lot number of the device was noted to be defective.The patients past medical history included abdominal hernia.The patient past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2010, the patient started using seprafilm (lot - 09np130, (b)(6) 2011) for abdominal hernia repair.Several years later on (b)(6) 2012, the patient underwent an additional surgery to remove the seprafilm, which failed.It was alleged that the patient endured additional surgeries to treat mesh-related complications.The patient was injured severely and permanently and had suffered and would continue to suffer physical pain due to the defective device.Final diagnosis was physical pain and mesh-related complications.Corrective treatment: surgery for mesh-related complications; not reported for physical pain.Outcome: not recovered for physical pain; unknown for mesh-related complications.Seriousness criteria: required intervention and disability for both events.A product technical complaint was initiated and the results for the same were pending.Follow up information received on 13-sep-2018.No new information received.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME BIOSURGERY (SEPRAFILM/PACK); 76 new york avenue; framingham MA 01701
• Manufacturer (Section G): GENZYME BIOSURGERY (SEPRAFILM/PACK); 76 new york avenue; framingham MA 01701
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 7922619
• MDR Text Key: 122305648
• Report Number: 2246315-2018-00614
• Device Sequence Number: 1
• Product Code: MCN
• UDI-Device Identifier: 00801741031823
• UDI-Public: (01)00801741031823(17)110628(10)WBTIS137
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2011
• Device Model Number: 5959680
• Device Catalogue Number: 5959680
• Device Lot Number: 09NP130
• Was Device Available for Evaluation?: Yes
• 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; Disability