BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M BRAND AGEE CARPAL TUNNEL RELEASE SYSTEM (CTRS)

    MDR report key: 167900 · Received May 13, 1998

    Report

    Report Number
    2110898-1998-00012
    Event Type
    Injury
    Date Received
    May 13, 1998
    Date of Event
    March 29, 1996
    Manufacturer
    HAZELTON ST JOSEPH'S MEDICAL CENTER
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT ALLEGES THAT DURING AN ENDOSCOPIC CARPAL TUNNEL RELEASE PROCEDURE PERFORMED, THE COMMON DIGITAL NERVE IN HER LEFT HAND WAS INJURED. ACCORDING TO THE INFO CO HAD RECEIVED, WITH SCOPE IN PLACE AND BLADE EXTENDED, PT BECAME RESTLESS AND MOVED. ADD'L MEDICAL INTERVENTION REQUIRED? IT IS BELIEVED THAT THE PT WAS EXPLORED AND REPAIRED AT ANOTHER SURGICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M BRAND AGEE CARPAL TUNNEL RELEASE SYSTEM (CTRS) AGEE CTRS KIT WITH AUTOCLAVE EYEPIECE ENDOSCOPE HRX HAZELTON ST JOSEPH'S MEDICAL CENTER 81020 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention