BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCUMCISION CLAMP SIZE 1.3 CM

    MDR report key: 2028462 · Received March 9, 2011

    Report

    Report Number
    2320762-2011-00002
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    October 21, 2010
    Report Date
    October 22, 2010
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    HFX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEROYAL REQUESTED ADDITIONAL INFORMATION REGARDING THE PATIENT AND HEALTHCARE WORKER'S INTERACTION WITH THE DEVICE AND HAVE NOT RECEIVED AND ACKNOWLEDGMENT OF OUR REQUEST FROM THE FACILITY REPORTING THE DEVICE MALFUNCTION. DEROYAL INITIALLY ADVISED THE VENDOR OF THE CIRCUMCISION CLAMP OF THE REPORTED COMPLAINTS AND ASKED FOR AN INVESTIGATION AND WRITTEN CONCLUSIVE EVALUATION. THE REQUEST INCLUDED DOCUMENTED AND VALIDATED CORRECTIVE AND PREVENTIVE ACTIONS TO BE TAKEN BY THE VENDOR TO PRECLUDE FURTHER CLAMP PROBLEMS. THE VENDOR'S INVESTIGATION, ONCE RECEIVED, ADVISED THAT THE WRONG MATERIALS, PEWTER INSTEAD OF BRASS, HAD BEEN USED IN THE MANUFACTURE OF CERTAIN LOTS OF CIRCUMCISION CLAMPS SHIPPED TO DEROYAL. THE ERROR COULD NOT BE DETECTED VISUALLY, HOWEVER, IT CAN BE DETECTED BY METAL ANALYSIS. THE VENDOR OF THE CIRCUMCISION CLAMP ADVISED DEROYAL THAT HIS CONTRACT MANUFACTURER WILL BE CHANGED DUE TO THE MATERIALS ERROR; HOWEVER, IN AN EFFORT TO HELP ASSURE QUALITY OF OUR DEVICE OFFERINGS, DEROYAL INDUSTRIES, INC., HAS CHOSEN TO SELECT A DIFFERENT VENDOR.

    Description of Event or Problem · 1

    CIRCUMCISION CLAMP FELL APART DURING THE CIRCUMCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCUMCISION CLAMP SIZE 1.3 CM CLAMP, CIRCUMCISION HFX DEROYAL INDUSTRIES, INC. 23434071

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK