BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAIMOND-FLEX 80MM ANGLED TRIANGULAR RETRACTOR

    MDR report key: 318143 · Received March 2, 2001

    Report

    Report Number
    1038548-2001-00012
    Event Type
    Injury
    Date Received
    March 2, 2001
    Report Date
    February 15, 2001
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE DISTAL END IS NOT RIGID ENOUGH AND TENDS TO DAMAGE THE LIVER. FURTHER INFO REVEALED THAT DURING A PROCEDURE, THE LIVER TISSUE WAS "PINCHED" OR "SCRATCHED". THE REPORTER NOTED THAT SEGMENTS ON THE RIGHT SIDE OF THE SHAPE FORMATION APPEARED WIDER THAN USUAL. THE PT DID NOT SUSTAIN AN INJURY AND AN INCIDENT REPORT WAS NOT FILED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9137 DAIMOND-FLEX 80MM ANGLED TRIANGULAR RETRACTOR RETRACTOR GAD GENZYME BIOSURGERY NA J99

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other