BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMAHAND-MERSILK SILK SUTURE

    MDR report key: 4791402 · Received May 22, 2015

    Report

    Report Number
    2210968-2015-04740
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    March 18, 2015
    Report Date
    March 27, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF SAMPLE THAT BROKE AT THE SUTURE ATTACHMENT OF THE NEEDLE END WAS PERFORMED. INSTRUMENT MARKS WERE FOUND AT THE ATTACHMENT AREA AND DIRECTLY AT THE BREAKING POINT WHICH INDICATES THAT THE NEEDLE WAS HANDLED THERE. THE DEVICE INFORMATION FOR USE CAUTIONS THE USER THAT "TO AVOID DAMAGING NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT." 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 DENTAL SURGERY ON (B)(6) 2015 AND SUTURE WAS USED. WHILE SUTURING GINGIVA TISSUE, THE NEEDLE BROKE. ADDITIONAL DISSECTION WAS REQUIRED TO RETRIEVE THE NEEDLE PIECE, WHICH WAS RECOVERED BY THE SURGEON WITHOUT DIFFICULTY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334371 PERMAHAND-MERSILK SILK SUTURE SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. UNK GDE275

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention