BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKNATEL SURGICAL SUTURES, NON-ABSORBABLE, 26MM

    MDR report key: 2110979 · Received April 12, 2011

    Report

    Report Number
    3004365956-2011-00134
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 16, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: CONCLUSIONS: NO EVAL WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN DUE TO LACK OF LOT NUMBER AND LACK OF SAMPLE. IF ADDITIONAL INFO IS RECEIVED ON THIS COMPLAINT, A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE EVENT REPORTED AS: "PT WAS HAVING VAGINAL HYSTERECTOMY, CULDOPLASTY, ANTERIOR BILATERAL SACROSPINOUS FIXATION, ANTERIOR AND POSTERIOR REPAIR AND CYSTOSCOPY. USING THE BOSTON SCIENTIFIC CAPIO DEVICE DURING SACROSPINOUS FIXATION PORTION, SURGEON PLACED SUTURE THROUGH THE LEFT SACROSPINOUS LIGAMENT AND PULLED ON THE SUTURE. WHILE DOING SO, THE BULLET OF THE SUTURE AVULSED. DESPITE USE OF RETRACTORS AND HEADLAMP, BULLET TIP COULD NOT BE ISOLATED. SURGEON OPTED TO LEAVE IN PLACE TO AVOID FURTHER COMPLICATION." NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEKNATEL SURGICAL SUTURES, NON-ABSORBABLE, 26MM SURGICAL SUTURES GAT TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1