BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT CIRCUMCISION STRAP, INFANT

    MDR report key: 1454765 · Received April 29, 2009

    Report

    Report Number
    9616096-2009-00003
    Event Type
    Malfunction
    Date Received
    April 29, 2009
    Date of Event
    March 30, 2009
    Report Date
    April 29, 2009
    Manufacturer
    KIMBERLY CLARK CORPORATION
    Product Code
    OHG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD CANNOT BE REVIEWED. INVESTIGATION IS IN-PROCESS. SUPPLEMENTAL REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT & MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK HAS RECEIVED A COMPLAINT THAT INDICATING THAT THE STRAPS ARE COMING APART AT THE VELCRO CONNECTION WHEN NO PRESSURE HAS BEEN APPLIED. THE USER HOSPITAL HAS NOT REPORTED ANY INJURIES RELATED TO THIS PRODUCT PROBLEM. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT CIRCUMCISION STRAP, INFANT CIRCUMCISION SET OHG KIMBERLY CLARK CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1