BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILE CIRCUMCISION CLAMP

    MDR report key: 2013471 · Received March 7, 2011

    Report

    Report Number
    MW5019694
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 19, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    HFX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER APPLYING BELL AND CLAMP AND COMPLETELY TIGHTENING SCREW, THE CLAMP LOOSENED AND WOULD NOT TIGHTEN AGAIN, ALTHOUGH THE SCREW WAS DOWN TO THE BOTTOM OF CLAMP. DATES OF USE: (B)(4) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE CIRCUMCISION CLAMP GOMCO CIRC. CLAMP HFX CARDINAL HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention