MAUDE Adverse Event Report: GENZYME CORPORATION(FRAMINGHAM) SEPRAFILM; MCN

Device Problems Malposition of Device (2616); Material Deformation (2976)

Patient Problems Peritonitis (2252); No Code Available (3191)

Event Date 01/24/2020

Event Type  Injury  

Event Description

Ileus [ileus] peritonitis [peritonitis] case narrative: initial information received on 05-feb-2020 regarding an unsolicited valid serious case received from (b)(6) pcp under reference on 05-feb-2020 and transmitted to sanofi.This case involves a (b)(6) old male patient who experienced peritonitis and ileus, while he using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing colon cancer.Underlying disease: cancer of sigmoid colon.Concurrent condition: none.Historical condition: none.Allergy history: none.History of adverse drug reactions: none.On (b)(6) 2020, the patient used seprafilm (lot number, unknown) for laparoscopic high anterior resection.Application site: immediately below the wound.Number of used seprafilm: qtr 1 pack.Concomitant use of other medical devices: presence (autosuture device and drain) on (b)(6) 2020, peritonitis developed.Development site: different from the application site whether bacterial culture was performed and the result: none after opening the abdominal cavity, it was found that the seprafilm was curled and moved from the application site.On an unknown date, the peritonitis resolved with sequela (ileus).On an unknown date, outcome of the ileus was unknown.The patient developed an event of a serious peritonitis.This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious ileus.This event was assessed as medically significant and was leading to intervention.Final diagnosis was moderate peritonitis and ileus.An unknown corrective treatment was received.The patient outcome is reported as recovered/resolved with sequelae on an unknown date for peritonitis and as unknown for ileus.Reporter comment: peritonitis: causal relationship of the event to seprafilm: unknown.Other possible factors suspected as the cause of the event: unknown.Peritonitis developed, and after opening the abdominal cavity, it was found that the seprafilm was curled and moved from the application site, which might be the factor for the event.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• Manufacturer (Section G): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 9721254
• MDR Text Key: 196104348
• Report Number: 1220423-2020-00011
• 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
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 02/07/2020

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR