BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 2 36 UNDYED GS-13

    MDR report key: 4006323 · Received August 7, 2014

    Report

    Report Number
    1219930-2014-00639
    Event Type
    Injury
    Date Received
    August 7, 2014
    Report Date
    July 15, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY US SURG
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: NEUROMUSCULAR. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT AFTER FITTING A PTG, THE "DEEP" SUTURE OF THE QUADRICEPS BROKE. THE PATIENT HAD TO BE RE-ADMITTED FOR SURGERY. (IT SEEMS LIKE THE THREAD RESORBS ITSELF PREMATURELY: THE SURGEON).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462372 POLYSORB 2 36 UNDYED GS-13 POLYSORB GAM COVIDIEN LP, FORMERLY US SURG

    Patients

    Seq Age Sex Outcome Treatment
    1