BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A.M.I HAL/RAR SYSTEM

    MDR report key: 2682711 · Received July 27, 2012

    Report

    Report Number
    3005049530-2012-00001
    Event Type
    Injury
    Date Received
    July 27, 2012
    Report Date
    July 27, 2012
    Manufacturer
    A.M.I. GMBH
    Product Code
    IYN
    PMA / PMN Number
    K061831
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR CONTACTED THE HOSPITAL FOR A GENERAL SALES CALL AND WAS INFORMED OF THE INCIDENT. THE DEVICE FUNCTIONED APPROPRIATELY AND THERE WAS NO ISSUE DURING THE PROCEDURE ITSELF. SEVERAL ACCESSORIES ARE PROVIDED BY THE MFR FOR USE WITH THE DEVICE. THESE INCLUDE SINGLE USE PROBE AND SLEEVE PROVIDED STERILE. ALSO PROVIDED NOT STERILE ARE A HANDLE, KNOT PUSHER AND A NEEDLEHOLDER. THE STERILIZATION RECORDS OF THE PROBE AND SLEEVE WERE REVIEWED AND FOUND IN ORDER. NO OTHER INCIDENTS OF INFECTION WERE REPORTED WITH THAT LOT ANYWHERE IN THE WORLD. THE LOT NUMBER FOR THE STERILE PROBE AND SLEEVE WAS NOT PROVIDED BY THE HOSPITAL BUT THE HOSPITAL ONLY RECEIVED TWO LOT NUMBERS. THIS PROCEDURE ALSO REQUIRES THE USE OF NEEDLES AND SUTURES AND OTHER SURGICAL INSTRUMENTS (I.E. SURGICAL SCISSORS) NOT PROVIDED BY A.M.I. (B)(4). THERE IS NOT DIRECT EVIDENCE OR INDICATION FROM THE SURGEON THA AN A.M.I. (B)(4) PRODUCT IS THE SOURCE OF THE INFECTION. THE MEDICAL DEVICE IS BEING RETRIEVED FOR INVESTIGATION.

    Description of Event or Problem · 1

    A.M.I. INC. WAS FOUND ON (B)(6) 2012 THAT PT HAD BEEN TREATED FOR HEMORRHOIDS ON AN UNSPECIFIED DATE WITH A.M.I. HAL/RAR SYSTEM. POST OPERATIVELY, THE PT DEVELOPED A CASE OF NECROTIZING FASCIITIS RESULTING IN LOSS OF TISSUE AND SIX WEEKS OF HOSPITALIZATION. THE PT WAS REPORTED TO BE DIABETIC AND OBESE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A.M.I HAL/RAR SYSTEM HARL/RAR SYSTEM FOR HEMORRHOID TREATMENT IYN A.M.I. GMBH AHE 203 070251-032

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening