BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELOSORB 2-0 UD 30 C-13

    MDR report key: 3027172 · Received March 22, 2013

    Report

    Report Number
    3006981798-2013-00002
    Event Type
    Malfunction
    Date Received
    March 22, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    RIVERPOINT MEDICAL, LLC
    Product Code
    GAM
    PMA / PMN Number
    K120556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: TYMPANOPLASTY. CUSTOMER REPORTED THAT WHEN FINISHING THE PROCEDURE IN ORDER TO BEGIN TO SUTURE INTRADERMICALLY, WHEN PLACING PRESSURE ON THE DISTAL PART OF THE SUTURE WHILE TYING THE KNOT, THE SUTURE BREAKS, THERE WAS NO REPORTED PROBLEM WITH THE PT. NO BLEEDING OR TISSUE LOSS. AN ADDITIONAL SUTURE WAS USED TO COMPLETE THE PROCEDURE. THE CLINICAL SAMPLE WAS DISCARDED. CUSTOMER DOES NOT REMEMBER THE DATE OF THE PROCEDURE, PT DATA, LOT NUMBER, ONLY REMEMBERS PROCEDURE TYPE AND REFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120506 VELOSORB 2-0 UD 30 C-13 SUTURE, ABSORBABLE, SYNTHETIC, PGA GAM RIVERPOINT MEDICAL, LLC SV2299

    Patients

    Seq Age Sex Outcome Treatment
    1