BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.102 STERILE

    MDR report key: 7101300 · Received December 8, 2017

    Report

    Report Number
    1836161-2017-00125
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    November 7, 2017
    Report Date
    December 8, 2017
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    GAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING SHOULDER SURGERY, ITEM 216705 (1/2 CIRCLE TAPER NEEDLE) BROKE AT THE PROXIMAL END OF THE NEEDLE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880208 NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.102 STERILE SURGICAL NEEDLE GAB ASPEN SURGICAL PRODUCTS, CALEDONIA 216705 108334

    Patients

    Seq Age Sex Outcome Treatment
    1 Other