FDA Adverse Event Other Summary report: N

SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

MDR report key: 1061712 · Received June 17, 2008

Report

Report Number
1220423-2008-00027
Event Type
Other
Date Received
June 17, 2008
Report Date
June 12, 2008
Manufacturer
GENZYME BIOSURGERY (SEPRAFILM/PACK)
Product Code
MCN
PMA / PMN Number
P950034
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
WI, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

FAT NECROSIS [SLURRY] [FAT NECROSIS], CHRONIC PELVIC PAIN [SLURRY] [PELVIC PAIN], FIBROHISTIOCYTIC REACTION [SLURRY] [INFLAMMATION], PELVIC ADHESIONS [SLURRY] [PELVIC PERITONEAL ADHESIONS]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 13-JUN-2008 FROM A COMPANY REP REGARDING A FEMALE PT OF UNK AGE AND INITIALS WHO EXPERIENCED CHRONIC PELVIC PAIN. ADHESIONS, FIBROHISTIOCYTIC REACTION AND FAT NECROSIS AFTER RECEIVING SEPRAFILM. THE PT UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ON AN UNK DATE IN (B) (6) 2007 DUE TO CHRONIC PELVIC PAIN. DURING SURGERY, A SEPRAFILM PROCEDURE PACK OF SIX SHEETS, 5X3 WERE PLACED AT THE VAGINAL CUFF IN THE PELVIC AREA AS "SLURRY'. IT WAS UNK IF ANY IRRIGANT FLUIDS WERE USED DURING SURGERY, LATEX OR POWDERED GLOVES WERE USED, PRODUCTS WERE LEFT BEHIND IN THE ABDOMINAL CAVITY OR IF CATGUT OR SILK SUTURES WERE USED. THE PT'S PELVIC PAIN PERSISTED AFTER THE PROCEDURE. ON AN UNSPECIFIED DATE IN (B) (6) 2008, THE PT WAS REFERRED TO A GASTROINTESTINAL SPECIALIST FOR COLONOSCOPY. COLONOSCOPY RESULTS WERE REPORTED AS "CLEAN". FURTHER IMAGING (TYPE AND RESULTS UNK) WAS PERFORMED ON UNSPECIFIED DATES IN (B) (6) 2008. THE PT'S PELVIC PAIN PERSISTED. ON (B) (6)2008, THE PT HAD A LAPAROSCOPY PERFORMED FOR LYSIS OF ADHESIONS, WHICH WERE BIOPSIED. PATHOLOGY RESULTS REPORTED THAT THE LEFT PERITONEAL VAGINAL CUFF, RIGHT PERITONEAL AND LEFT SIDE WALL WERE "IN LINE" WITH FIBROHISTIOCYTIC REACTION AND FAT NECROSIS. AT THE TIME OF THIS REPORT, THE PT WAS STILL EXPERIENCING CHRONIC PELVIC PAIN.

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 UNK Other| R