BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 2181818 · Received July 28, 2011

    Report

    Report Number
    2210968-2011-01003
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    May 20, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ETHICON
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DIFFICULTY WITH URINATION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF THE ANTERIOR WALL OF THE STOMACH ON (B)(6) 2011 AND SUTURE WAS USED TO CLOSE THE ABDOMEN, PERITONEUM AND ANTERIOR THECA. ON (B)(6) 2011, THE PATIENT'S INCISION HAD EXUDATES. ON (B)(6) 2011, THE PATIENT HAD AN INFECTION. THE SURGEON OPENED THE INCISION AND FOUND A PUS POCKET. THE INFECTION WAS AROUND THE SUTURE AND HAD FORMED AN ABSCESS. THE SURGEON CRUSHED THE INCISION AND THE PUS OOZED FROM THE SUTURE. THE FASCIA WAS NECROTIC AND SUPPURATION OF PUS OCCURRED. ONE DAY AFTER THE SURGERY, THE PATIENT HAD FEVER, USUALLY BETWEEN 37.5 TO 38.5 DEGREES CENTIGRADE. TWO DAYS AFTER THE SURGERY, THE PATIENT'S BODY TEMPERATURE HAD RECOVERED. THIRTY DAYS AFTER THE PROCEDURE, THE PATIENT'S BODY TEMPERATURE WAS 40 TO 41 DEGREES CENTIGRADE. THE FEVER USUALLY OCCURRED IN THE AFTERNOON OR NIGHT. TEN DAYS AFTER THE SURGERY, THE PATIENT EXPERIENCED SINGULTUS. THE SURGEON USED ACUPUNCTURE, PHYSIATRICS AND (B)(6) DRUG, WHICH WERE USELESS. THE PATIENT HAD DIFFICULTY IN URINATION. THE PATIENT HAD SYMPTOMS OF SHIVERING, FEVER AND DIAPHORESIS WHICH LASTED ABOUT ONE MONTH. THE PATIENT HAD A PERITONEAL CAVITY ULTRASOUND AND HYDROPS WAS NOT SEEN. THERE WAS NO LUNG INFECTION, AND BLOOD CULTURES WERE NEGATIVE. THE PATIENT WAS TREATED WITH CLINDAMYCIN, BUT THEN CHANGED TO AZTREONAM, PAZUFLOXACIN AND METRONIDAZOLE WHEN THE FEVER APPEARED. THE PATIENT STOPPED USING ALL ANTIBIOTICS ON (B)(6) 2011, BUT CONTINUED MEDICINE FOR HYPERTENSION AND DIABETES MELLITUS. RECENTLY, THE PATIENT USED AZTREONAM BECAUSE OF FEVER AND QINGKAILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE, ABSORBABLE GAM ETHICON NA DBM079

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention