BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 2/0 30 U/D GS-11 213Q

    MDR report key: 5698117 · Received June 3, 2016

    Report

    Report Number
    1219930-2016-00583
    Event Type
    Injury
    Date Received
    June 3, 2016
    Date of Event
    April 23, 2016
    Report Date
    May 9, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT-DEVICE INCOMPATIBILITY; NO SPECIFIC PERFORMANCE ISSUE WAS ASSOCIATED WITH THE DEVICE. THE ONLY INFORMATION KNOWN IS THAT A LOCAL REACTION WAS SEEN IN THE PATIENT AFTER THE APPLICATION OF THE DEVICE AND EVIDENCE OF AN INFECTION OR HYPERSENSITIVITY WAS NOT FOUND. THE REACTION ALSO HAS SINCE RESOLVED AND THE SUTURE WAS NOT REPORTED TO HAVE REQUIRED REMOVAL.

    Additional Manufacturer Narrative · 1

    FTR# (B)(4). EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THREE PHOTOGRAPHS OF AN INCIDENT INVOLVING DEVICE. THE INITIAL VISUAL INSPECTION OF THE INSTRUMENT BY THE PMV INVESTIGATOR NOTED THREE PHOTOS SHOW REDDENING OF THE SKIN AROUND THE SUTURED AREA. A YELLOW GOO-LIKE SUBSTANCE WAS ALSO EXUDING FROM THE SUTURE LINE AREA. UNFORTUNATELY, BASED ON THE EVIDENCE AVAILABLE, A POTENTIAL ROOT CAUSE COULD NOT BE IDENTIFIED. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER; ON (B)(6) 2016 THE PATIENT, FEMALE, UNDERWENT A HIP REPLACEMENT PROCEDURE IN WHICH THE SUTURE DEVICE WAS USED. ON (B)(6) 2016, DRAINAGE OF THE HIP INCISION OCCURRED SIGNIFICANT ERYTHEMA AROUND THE INCISION WAS NOTICED. THE PATIENT RETURNED TO AN ER BECAUSE OF INFLAMMATION AROUND THE INCISION BUT WAS NOT FEVERISH AND HAD NORMAL WHITE BLOOD CELL COUNT. NO EVIDENCE OF INFECTION WAS FOUND AND A REACTION TO THE SUTURE AT THE INCISION SITE WAS PRESUMED. THE PRODUCT WILL NOT BE RETURNED AS THE SUTURE IS STILL IN THE PATIENT. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES. NO DEVICE FRAGMENT FELL INTO THE PATIENT. THE PATIENT HAS SINCE BEEN SEEN WEEKLY AND WAS LAST SEEN ON 5/11 AND IS SAID TO HAVE NO IMMUNE ISSUES OR HYPER ALLERGIES. IT WAS ALSO PROVIDED THAT A 1-0 POLYSORB SUTURE WAS ALSO USED FOR "DEEPER LAYERS" HOWEVER NO ASSOCIATION TO THIS DEVICE WAS MADE IN REGARD TO THE SYMPTOMS EXPERIENCED AND IS CONSIDERED A CONCOMITANT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352166 POLYSORB 2/0 30 U/D GS-11 213Q SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN, FORMERLY US SURGICAL A DIVISON CL543

    Patients

    Seq Age Sex Outcome Treatment
    1 Other