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

Device Problem Nonstandard Device (1420)

Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Pain (1994); Renal Failure (2041)

Event Type  Injury  

Event Description

This unsolicited device case from united states was received on (b)(6) 2015 from a patient.This case involves a (b)(6) year old female patient who developed phase iii renal failure, recurrent bacterial infections, boils around the wound and constant pain on her right side after receiving treatment with seprafilm.The patient's medical history, past drugs, concurrent conditions and concomitant medications were not reported.The patient experienced open surgery to remove her ovaries in (b)(6) 2008.On an unknown date in (b)(6) 2008, the patient received treatment with seprafilm, once (number of sheets, anatomical location, batch/lot number and expiration date: unknown) as postoperative adhesion.On an unknown date, the patient experienced boils around the wound and recurrent bacterial infections for the last seven years.It was reported that the patient just found out that seprafilm was on recall at the time of her surgery which was unknown to her at the time of her surgery.The hospital was notified in (b)(6) 2008 that the seprafilm was under recall.On an unknown date, the surgery was performed in a medical centre.The patient experienced an increase in her serum creatinine since her surgery and her most recent serum creatinine was 1.3 (units and normal ranges: not provided).It was reported that the patient's physicians did not know why her serum creatinine had gone up.On an unknown date, the patient was diagnosed with phase iii renal failure.Also on an unknown date, the patient had constant pain on her right side where the most seprafilm was placed.Corrective treatment: not reported for all the events.Outcome: not recovered/not resolved for all the events.Seriousness criteria: important medical event for the event of phase iii renal failure.

Manufacturer Narrative

A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Pharmacovigilance comment: sanofi company comment date: this initial case concerns a female patient who experienced renal failure after seprafilm administration as postoperative adhesion barrier.As the date of onset of renal failure is not provided, definite temporal relationship between the product and event could not be established, however, lack of detailed information regarding medical history, concurrent illness, concomitant medications, lab reports leads to incomplete assessment of the case.

• Brand Name: SEPRAFILM
• Type of Device: BIORESORBABLE ADHESION BARRIER
• Manufacturer (Section D): GENZYME BIOSURGERY (SEPRAFILM/PACK); framingham MA
• Manufacturer Contact: kristen sharma, md ; 55 corporate dr; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4502051
• MDR Text Key: 5333501
• Report Number: 1220423-2015-12864
• 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: Consumer
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 01/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CON MEDS = UNKNOWN, PREV MEDS = UNKNOWN
• Patient Outcome(s): Other
• Patient Age: 53 YR