FDA Adverse Event Injury Summary report: N

SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

MDR report key: 3261256 · Received July 31, 2013

Report

Report Number: 1220423-2013-00016
Event Type: Injury
Date Received: July 31, 2013
Report Date: July 23, 2013
Manufacturer: GENZYME BIOSURGERY (SEPRAFILM/PACK)
Product Code: MCN
PMA / PMN Number: P950034
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MANUFACTURER'S COMMENT: AS ONLY LIMITED INFO HAS BEEN OBTAINED SO FAR, IT IS DIFFICULT TO ASSESS A CAUSE AND EFFECT RELATIONSHIP.

Description of Event or Problem · 1

SMALL BOWEL OBSTRUCTION [SMALL INTESTINAL OBSTRUCTION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PT, INITIALS UNK. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OVARIAN CANCER. IN AN UNSPECIFIED DATE, THE PT WAS TREATED SURGICALLY FOR OVARIAN CANCER BY TUMOR DE BULKING VIA AN OPEN MIDLINE INCISION, AND SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE WAS PLACED UNDER THE MIDLINE INCISION PRIOR TO CLOSE (NUMBER OF SHEETS NOT PROVIDED). THE LOT NUMBER FOR SEPRAFILM WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, ONE YEAR AFTER SURGERY, THE PT HAD SMALL BOWEL OBSTRUCTION IN THE VICINITY OF MIDLINE INCISION, FOR WHICH THE PT WAS HOSPITALIZED. ON AN UNSPECIFIED DATE, THE PT RECOVERED FROM THE EVENT. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS NOT PROVIDED. THE RELATIONSHIP OF SEPRAFILM WITH THE EVENT WAS NOT PROVIDED BY THE REPORTING PHYSICIAN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
358087	SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE	BIORESORBABLE ADHESION BARRIER	MCN	GENZYME BIOSURGERY (SEPRAFILM/PACK)	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Hospitalization