BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOGEN CLAMP

    MDR report key: 5732870 · Received June 7, 2016

    Report

    Report Number
    MW5062902
    Event Type
    Injury
    Date Received
    June 7, 2016
    Date of Event
    March 19, 2010
    Report Date
    June 6, 2016
    Product Code
    HFX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DR. (B)(6) M.D. PERFORMED A ROUTINE CIRCUMCISION ON THE PATIENT AND TIP OF THE PENIS WAS AMPUTATED. THE COO WAS SERVED A CIVIL ACTION COMPLAINT ON (B)(6) BY THE (B)(6). THE LAW FIRM REPRESENTING THE PLAINTIFF INITIATED A FIRST AMENDED COMPLAINT AND JURY DEMAND CLAIMING NEGLIGENCE AND PRODUCT LIABILITY. THE COMPANY KNOWS OF THIS CLAIM ONLY THROUGH THE CIVIL ACTION OF THE PLAINTIFFS. NO MEDWATCH REPORT WAS FILED BY THE DOCTOR INVOLVED, THE MEDICAL FACILITY, NOR THE PLAINTIFFS. THEREFORE, SKLAR HAS NO MEDICAL PROOF OR EVIDENCE OF THE ALLEGED INJURIES. THE ONLY EVIDENCE OF THE DEVICE IS A LOW RESOLUTION PHOTOGRAPH. BASED ON THIS PHOTO, THE INSTRUMENT HAS A "MISDOM FRANK" MARKING AND ALSO THE MARKING OF A COMPETITOR "LAWTON" WITH LAWTON'S UNIQUE PRODUCT IDENTIFICATION NUMBER. SKLAR EXAMINED ITS FILES FOR THE LAST 15-20 YEARS AND HAS NO RECORD OF PURCHASING, NOR SELLING THE SUBJECT DEVICE. ALSO, THE COMPANY DOES NOT CURRENTLY, AND HAS NEVER MANUFACTURED THE DEVICE WITHOUT INSPECTING THE SUBJECT DEVICE, SKLAR BELIEVES THAT IT IS A COMPETITOR'S INSTRUMENT AND IS UNABLE TO TAKE FURTHER ACTION OTHER THAN THIS NOTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359959 MOGEN CLAMP MOGEN CLAMP HFX UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention