BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL RAP UND 45CM 4/0 PS-2 PRIME MP

    MDR report key: 8226311 · Received January 8, 2019

    Report

    Report Number
    2210968-2019-78253
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Report Date
    December 12, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THERE ANY ANTIBIOTICS-MEDICATION /TREATMENT OR MEDICAL/RE-SUTURING/SURGICAL INTERVENTION PROVIDED TO THE PATIENT POST-OP AS A RESULT OF THE EVENT REPORTED? NO ANTIBIOTICS / TREATMENT OR SURGICAL INTERVENTION WAS REQUIRED. IT APPEARED THE PATIENTS¿ TISSUE HAD ACHIEVED ADEQUATE SELF SUPPORT. PATIENT CURRENT CONDITION IF KNOWN? PATIENT IS WELL ¿ NO COMPLICATIONS PATIENT¿S INFORMATION SUCH AS, DOES THE PATIENT HAVE ANY OTHER CO-MORBIDITIES? LIFESTYLE E.G. ALCOHOL INTAKE? NO UNUSUAL PATIENT FACTORS / CO MORBIDITIES / LIFESTYLE CHOICES TO NOTE. ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL FRENECTOMY PROCEDURE IN 2018 AND A SUTURE WAS USED. THE SURGEON FOUND THAT THE SUTURE APPEARED TO BE COMPLETELY ABSORBED ONLY FIVE DAYS AFTER THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21348 VICRYL RAP UND 45CM 4/0 PS-2 PRIME MP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AK6374

    Patients

    Seq Age Sex Outcome Treatment
    1