BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO CIRCUMCISION CLAMP NEWB 13MM

    MDR report key: 6077717 · Received November 3, 2016

    Report

    Report Number
    2916714-2016-00905
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 6, 2016
    Report Date
    April 7, 2017
    Manufacturer
    CONTRACT MANUFACTURER: SUPERIOR SURGICAL LLC
    Product Code
    HFX
    PMA / PMN Number
    PRE-AMENDMEN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE REPORTED ISSUE DETERMINED THAT THE DEVICE WAS IMPROPERLY USED. RECALL OF DEVICE CONDUCTED UNDER RECALL NUMBER 2916714-10/18/2016-015R.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINTS: USA. IT WAS REPORTED THAT DURING A CIRCUMCISION, THE DEVICE HAS A LOOSE FITTING ISSUE AROUND THE BELL, WHICH RESULTS IN INADEQUATE COMPRESSION OF THE FORESKIN. THIS RESULTED IN EXCESSIVE BLEEDING AND A POOR OUTCOME FOR THE PATIENTS ON FOUR SEPARATE OCCASIONS. THE CLAMP WAS LEFT IN PLACE FOR AN ADDITIONAL 5 MINUTES, BUT THE BLEEDING WAS CONSISTENT. HARM TO PATIENTS WAS EXCESSIVE BLEEDING AND POOR OUTCOME. DELAY IN SURGERIES ARE UNKNOWN. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 2916714-2016-00902, 2916714-2016-00903, 2916714-2016-00904, 2916714-2016-00905.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727201 GOMCO CIRCUMCISION CLAMP NEWB 13MM GENERAL SURGICAL INSTRUMENTS HFX CONTRACT MANUFACTURER: SUPERIOR SURGICAL LLC MG097R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other