BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSUFFLATOR

    MDR report key: 97915 · Received June 13, 1997

    Report

    Report Number
    2936485-1997-00007
    Event Type
    Injury
    Date Received
    June 13, 1997
    Report Date
    June 11, 1997
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    FCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE INSUFFLATOR OVER-INSUFFLATED THE PATIENT CAUSING SUBCUTANEOUS CREPITUS IN THE CHEST, NECK AND THIGHS. NO OTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSUFFLATOR INSUFFLATOR FCX STRYKER ENDOSCOPY 620-30-200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention