BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 3881284 · Received June 18, 2014

    Report

    Report Number
    2210968-2014-07810
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS A LEFT PALMAR MASS EXCISION. THE PATIENT¿S PRE-OPERATIVE DIAGNOSIS WAS A GANGLION CYST AND THE SUTURE WAS PLACED IN THE PALM OF THE LEFT HAND. THE WOUND WAS CLEAN AND DRY ONE WEEK POST OPERATIVELY. AT WEEK TWO, THE WOUND WAS BEEFY RED GRANULATION AT THE APEX AND ONE SUTURE PULLED THROUGH THE EDGE OF THE INCISION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 HAND SURGERY ON (B)(6) 2014 AND SUTURE WAS USED. ONE TO TWO WEEKS FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED OOZING AND WEEPING WOUND WITH BEEFY RED APPEARANCE. THE PATIENT POSSIBLY RECEIVED ANTIBIOTICS OR PEROXIDE SOAKS AND BETADINE SWABS. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357619 ETHILON NYLON SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. UNK GJB940

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention