BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 1251748 · Received December 3, 2008

    Report

    Report Number
    2210968-2008-01208
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAR
    PMA / PMN Number
    N85316
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT DEVELOPED SKIN ITCHING, REDNESS AND INFLAMMATION AT THE SURGICAL SITE 4-5 DAYS FOLLOWING MOLE EXCISION. NO MEDICAL TREATMENT WAS WARRANTED. THE SYMPTOMS PERSISTED AFTER ROUTINE SKIN SUTURE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHILON NYLON SUTURE SUTURE, NONABSORBABLE GAR ETHICON, INC. NA ZH2CMHP1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other