BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL GUT SUTURE - CHROMIC

    MDR report key: 4810963 · Received June 2, 2015

    Report

    Report Number
    2210968-2015-06549
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 8, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    GAL
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM TO HAVE THE WOUND FLUSHED OUT AND DEBRIDED. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE POSSIBLE BATCH NUMBERS: BATCH JBK178 MFG DATE: 02/19/2015, EXP DATE: 07/31/2019, BATCH HL6268 MFG DATE: 10/15/2014, EXP DATE: 07/31/2019. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA. REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR STRENGTH AND THEY MET REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE PATIENT UNDERWENT CARPAL TUNNEL SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED INFLAMMATION, INFECTION OR DEHISCENCE. THE PATIENT WAS TAKEN BACK TO THE OR AND UNDERWENT WASH OUT OF THE WOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354226 SURGICAL GUT SUTURE - CHROMIC SUTURE, ABSORBABLE, NATURAL GAL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention