BEUDAMED
    FDA Adverse Event Other Summary report: N

    S-VAC AND FLUTED DRAIN

    MDR report key: 2987925 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00058
    Event Type
    Other
    Date Received
    February 22, 2013
    Date of Event
    September 16, 2011
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO A RECENT (B)(4) INSPECTION, THIS MDR IS BEING REPORTED LATE AS A RESULT OF A RE-EVALUATION.

    Description of Event or Problem · 1

    DRAIN BROKE OFF AT THE HUB. FURTHER INFORMATION INDICATED THAT THE DRAIN WAS TOO LONG AND WAS CUT BY THE TECH AND TEN CUT AGAIN BY THE DOCTOR. REVIEW BY A SECOND PHYSICIAN ON (B)(6) 2011 SHOWED THAT THE DEVICE WAS NOT BROKEN OFF AT THE HUB BUT WAS CUT VERY CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77504 S-VAC AND FLUTED DRAIN WOUND DRAINAGE GCY ASPEN SURGICAL PRODUCTS, INC. 2016-06-03

    Patients

    Seq Age Sex Outcome Treatment
    1