SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

MDR report key: 2831330 · Received November 5, 2012

Report

Report Number: 1220423-2012-00042
Event Type: Injury
Date Received: November 5, 2012
Date of Event: October 28, 2012
Report Date: October 31, 2012
Manufacturer: GENZYME BIOSURGERY (SEPRAFILM/PACK)
Product Code: MCN
PMA / PMN Number: P950034
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MFR'S COMMENT: THE RISK-BENEFIT RELATIONSHIP OF THE SEPRAFILM IS NOT AFFECTED BY THIS REPORT.

Description of Event or Problem · 1

PERITONITIS AT PELVIC FLOOR [INFECTIOUS PERITONITIS]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PT, INITIALS UNK. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR DYSPLASIA OF CERVIX (UTERI). ON (B)(6) 2012, THE PT UNDERWENT TOTAL HYSTERECTOMY OPERATION FOLLOWED BY APPLICATION OF SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE. THE LOT NUMBER FOR SEPRAFILM WAS NOT PROVIDED. ON (B)(6) 2012, THE PT DEVELOPED LIFE THREATENING PERITONITIS AT PELVIC FLOOR AT THE LOCATION WHERE SEPRAFILM WAS PLACED. THE PT HAD NOT YET RECOVERED FROM THE EVENT OF PERITONITIS AT PELVIC FLOOR AS OF (B)(6) 2012. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF PERITONITIS AT PELVIC FLOOR WAS SEVERE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENT OF PERITONITIS AT PELVIC FLOOR AS PROBABLE. THE REPORTING PHYSICIAN DID NOT CONSIDER THE EVENT TO BE CAUSED BY INFECTION AND ANY OTHER CAUSE ASSOCIATED WAS UNK.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Life Threatening