MAUDE Adverse Event Report: GENZYME BIOSURGERY (SEPRAFILM/PACK) SEPRAFILM (SEPRAFILM); BIORESORBABLE ADHESION BARRIER

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Peritonitis (2252)

Event Type  Injury  

Event Description

This literature unsolicited device case was rec'd from (b)(6) on (b)(4) 2014 from an author via a literature abstract: (b)(4).From this publication one another case was also reported: (b)(4).The case involves a female pt (unspecified age) who developed sterile peritonitis after seprafilm placement.The pt's medical history, past drugs, concomitant medications or concurrent conditions were reported.On an unk date, the pt delivered via a caesarean section after which seprafilm was placed (number of sheets, anatomical location, lot/batch number and expiration date: unspecified) for postoperative adhesion.On an unk date after gynecological surgical procedure (cesarean section), the pt developed sterile peritonitis.It was reported that the pt mimicked intraabdominal abscess formation soon after the initial surgery (caesarean).However, laparoscopic examinations revealed only gel-like hydrated seprafilm w/o evidence of infection.On an unk date, the abdominal cavity was thoroughly irrigated and the seprafilm residue was completely removed.On an unk date, the pt had uneventful recovery.Corrective treatment: abdominal cavity irrigation.Outcome: recovered/resolved.Seriousness criteria: important medical event.A pharmaceutical technical complaint (ptc) was initiated and conclusion was pending for the same.

Manufacturer Narrative

Conclusion: seprafilm-related complications were most commonly observed in pts who underwent gynecologic debulking surgery because seprafilm might react with the large area of the injured peritoneum and induce a strong inflammatory response.However, our experience showed the such complications could also be observed in pts who underwent non-debulking surgery.Pharmacovigilance comment: sanofi company comment dated (b)(4) 2014: in this case, the causal role of seprafilm cannot be excluded for the occurrence of the event of sterile peritonitis, however the lack of info regarding the underlying medical history and the concomitant medications used by the pt precludes the complete case assessment.

• Brand Name: SEPRAFILM (SEPRAFILM)
• Type of Device: BIORESORBABLE ADHESION BARRIER
• Manufacturer (Section D): GENZYME BIOSURGERY (SEPRAFILM/PACK); framingham MA
• Manufacturer Contact: 55 corporate drive; mail stop: 55d-205a; bridgewater, NJ 08807 ; 9089816698
• MDR Report Key: 3682706
• MDR Text Key: 15114570
• Report Number: 1220423-2014-25232
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• PMA/PMN Number: P950034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CON MEDS =UNK; PREV MEDS =UNK
• Patient Outcome(s): Other