BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 1971549 · Received January 24, 2011

    Report

    Report Number
    1220423-2011-00002
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    November 4, 2010
    Report Date
    December 15, 2010
    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

    EVAL SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED THEREFORE; A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE (B)(6) PROCESS. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS.

    Description of Event or Problem · 1

    (B)(6) INFECTION/CULTURE TEST FOR PUS FROM MID-INCISION [WOUND INFECTION (B)(6)], WOUND BREAKDOWN [WOUND DEHISCENCE]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS REC'D FROM AN HCP (NURSE/PHARMACIST) ON (B)(6)-2010 REGARDING AN (B)(6), MALE, PT, INITIALS (B)(6), WHO EXPERIENCED A WOUND BREAKDOWN AFTER THE USE OF SEPRAFILM. THE RPTR STATED THAT ON 17(B)(6)-2010, THE PT HAD ADHESIOLYSIS FOR STRANGULATION ILEUS. THE PT HAD NO COMPLICATION BEFORE THE SURGERY. ALSO, NO OTHER CONCOMITANT MEDICAL DEVICE WAS USED. ONE SHEET OF SEPRAFILM OF AN UNK LOT NUMBER WAS CUT INTO EIGHT PIECES INCLUDING INNER POUCH AND THEN PLACED ON THE LARGE INTESTINE OF THE PT. ON (B)(6)-2010, THE PT DEVELOPED A WOUND BREAKDOWN AT THE INCISION AREA WHERE THE SEPRAFILM HAD BEEN PLACED. THE PT WAS HOSPITALIZED FOR AN UNSPECIFIED TREATMENT. PIECE(S) OF TRANSPARENT CELLOPHANE OF THE INNER POUCH WAS FOUND AT THE LOCATION WHERE THE SEPRAFILM WAS PLACED IN THE PT. ON (B)(6)-2010, THE PT RECOVERED. IN THE OPINION OF THE RPTR, THE EVENT OF WOUND BREAKDOWN WAS OF "MODERATE" INTENSITY AND WAS "UNRELATED" TO THE USE OF SEPRAFILM. THE RPTR STATED THAT PIECE(S) OF THE INNER POUCH WAS LEFT MISTAKENLY AT THE OPERATION SITE. AT THE TIME OF THIS REPORT, THE PT HAD COMPLETELY RECOVERED FROM THE ADVERSE EVENT. THE START DATE FOR THE EVENT WAS (B)(6)-2010 AND THE OFFSET DATE WAS (B)(6)-2010. ON (B)(6)-2011, ADD'L INFO WAS REC'D FROM THE HCP. THE HCP CONFIRMED THE EVENT OF "WOUND BREAKDOWN" IN THE PT AND PROVIDED THE PT'S MEDICAL HISTORY. THE PT HAS A HISTORY OF CEREBRAL PALSY, EPILEPSY, GASTROESOPHAGEAL REFLUX, FUNDOPLICATION (LAPAROSCOPIC SURGERY), AND GASTROSTOMY AROUND (B)(6) 2001. ON (B)(6)-2010, THE PT PRESENTED TO THE EMERGENCY FOR STRANGULATION ILEUS, AND WAS THEN TRANSFERRED TO THE SURGERY DEPARTMENT. ON (B)(6)-2010, THE PT HAD AN EMERGENCY OPERATION AT 0:55 HRS. THE NOTES REGARDING THE SURGERY STATE THAT THE CONDITION OF THE PT PRIOR TO THE OPERATION SHOWED MODERATE GENERALIZED MALNUTRITION STATUS, BUT NO ANEMIA. THE PT HAD NO PRIOR EXPERIENCE WITH NUCLEAR RADIATION THERAPY. THE PT HAD EXPERIENCED POSTOPERATIVE STRANGULATION ILEUS AND ADHESIOLYSIS WAS PERFORMED ON THE PT. THE HCP STATED THAT ADHESION WAS SEEN IN THE PT (LOCATION NOT PROVIDED) AND WAS DETACHED. NON-PURULENT INFLAMMATION EXISTED IN THE ABDOMINAL CAVITY BUT NO INFECTION WAS SEEN. INTRAPERITONEAL LAVAGE WAS PERFORMED. THE INCISION SITE WAS ABOUT 10 CM LONG AND HAD TWO LAYERS. THE FIRST (PERITONEUM) LAYER WAS KNOTTED WITH ABSORBABLE, MULTI AND SYNTHETIC SUTURES (VYCRIL). THE SKIN LAYER WAS SUTURED BY SKIN-STAPLER. THERE WAS NO PURULENT INFLAMMATION AND NO INFECTION WAS PRESENT. ONE SHEET OF SEPRAFILM WAS CUT UP INTO EIGHT PIECES INCLUDING THE INNER POUCH AND PLACED UNDER THE MID-INCISION AT THE ABDOMEN CLOSING. THERE WAS NO INFECTION PRESENT. THE CONCOMITANT MEDICATIONS THE PT WAS GIVEN WERE GENTAMICIN SULFATE 60MG/DAY INTRAVENOUSLY BETWEEN (B)(6)-2010 AND FLOMOXEF SODIUM 2G/DAY INTRAVENOUSLY BETWEEN (B)(6)-2010 AS PROPHYLAXIS FOR WOUND INFECTION. ON (B)(6)-2010, THE WOUND PARTIALLY OPENED WITH EXUDATE FLUID COMING OUT. LATER, THE AMOUNT OF FLUID REDUCED AND THE WOUND CLOSED. ON (B)(6)-2010, THE PT VISITED THE OUT-PT UNIT. A BLOOD SAMPLE WAS TAKEN ON (B)(6)-2010. THE WHITE BLOOD CELL COUNT WAS 4300 AND THE C-REACTIVE PROTEIN LEVEL WAS 0.12. THE PT WAS HOSPITALIZED DUE TO THIS EVENT. THE WOUND OPENED BY 3MM AND SOMETHING THAT LOOKED LIKE A FOREIGN BODY WAS EXPOSED. ON (B)(6)-2010, THE PT HAD A RE-LAPAROTOMY. THE INCISION WAS RESECTED BY 3CM AND THE FOREIGN BODY WAS EXTRACTED, IT WAS A PIECE OF THE INNER POUCH OF SEPRAFILM. A CULTURE TEST WAS CONDUCTED ON THIS DAY ON THE PUS TAKEN FROM THE MID INCISION TO TEST FOR AEROBIC AND ANAEROBIC ORGANISMS. (B)(6) WAS DETECTED. THE PT WAS GIVEN FLOXOMEF SODIUM 2G/DAY INTRAVENOUSLY BETWEEN (B)(6)-2010 AS PROPHYLAXIS FOR WOUND INFECTION. BY THIS TIME, THE SEPRAFILM WAS COMPLETELY ABSORBED INTO THE PT'S BODY AND A PIECE OF THE INNER POUCH WAS REMOVED. ON (B)(6)-2010, THE PT WAS DISCHARGED. THE REPORTING PHYSICIAN COMMENTED THAT HE SHOULD HAVE REMOVED THE FILM FROM THE INNER POUCH WHEN HE CUT IT, BUT IT WAS HARD TO DIFFERENTIATE THE SEPRAFILM FROM THE INNER POUCH. IN THE HCP'S OPINION, THE EVENT "WOUND BREAKDOWN" WAS OF "MODERATE" INTENSITY AND "DEFINITELY" RELATED TO THE USE OF SEPRAFILM IN THE PT. AT THE TIME OF THIS REPORT, THE PT HAD RECOVERED FROM THE ADVERSE EVENTS. THE ONSET DATE FOR THE WOUND BREAKDOWN WAS (B)(6)-2010 AND FOR (B)(6) INFECTION WAS (B)(6)-2010. THE OFFSET DATE FOR BOTH EVENTS WAS (B)(6)-2010. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.

    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 18 YR Hospitalization| O DATE OF TX: (B)(6) 2010| DATE OF TX: (B)(6) 2010| GENTAMICIN SULFATE (GENTAMICIN SULFATE)| FLOMOXEF SODIUM (FLOMOXEF SODIUM)