BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD/DAVOL SILICONE DRAIN

    MDR report key: 62945 · Received January 7, 1997

    Report

    Report Number
    1018233-1997-00001
    Event Type
    Other
    Date Received
    January 7, 1997
    Date of Event
    November 27, 1996
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GCY
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE ADDITIONAL INFO REC'D ON 1/28/97, IT IS BELIEVED THAT AN INTERNAL SUTURE ERRONEOUSLY PIERCED THE DRAIN & WAS NOT VISUALIZED PRIOR TO AN ATTEMPTED REMOVAL OF THE DRAIN. RESISTANCE WAS NOTED DURING THE REMOVAL ATTEMPT & FORCE WAS APPLIED. THIS INFO WAS PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD/DAVOL SILICONE DRAIN WOULD DRAIN-HUBLESS GCY C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR INFO RECEIVED THAT STATED IT WAS BELIEVED THAT AN| INTERNAL SUTURE PIERCED THE DRAIN.