BEUDAMED
    FDA Adverse Event Summary report: N

    PLASTIBELL 1-2 CM

    MDR report key: 308271 · Received November 24, 2000

    Report

    Report Number
    MW4002900
    Date Received
    November 24, 2000
    Date of Event
    November 21, 2000
    Report Date
    November 22, 2000
    Manufacturer
    HOLLISTER INC.
    Product Code
    FHG
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HAVE HAD SEVERAL STRINGS ON THE PRODUCT THAT HAVE BROKEN WHILE PERFORMING CIRCUMCISION. THE STRING BREAKS WHEN BEING TIGHTENED BEFORE KNOTTING IT AND REMOVING FORESKIN. HAVE BEEN TOLD REPEATEDLY BY THE CO THAT THEY HAVE NEVER RECEIVED A PRODUCT COMPLAINT OF THIS NATURE AND HAVE NO OTHER CENTERS REPORTING THIS PROBLEM.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/14/01: HOLLISTER INC HAD REQUESTED AND DID NOT RECEIVE SAMPLES OF DEVICE FROM THE USER FACILITY; THEREFORE, TESTING OF THE ACTUAL DEVICE COULD NOT BE PERFORMED. DURING THE INVESTIGATION, THE FACILITY REPORTED THAT THE BREAKAGE OF THE LIGATURE WAS OCCURRING WHEN USED BY ONE PHYSICIAN. THE FACILITY ALSO REPORTED THAT OTHER PHYSICIANS IN THE FACILITY HAVE USED THE DEVICE WITHOUT INCIDENT. HOLLISTER INC HAS REVIEWED ITS PRODUCT COMPLAINT FILES AND HAS DETERMINED THAT NO ADVERSE TRENDS EXIST FOR THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASTIBELL 1-2 CM CIRCUMCISION BELL FHG HOLLISTER INC. NA 7F11AL

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO