BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KCI WOUND VAC

    MDR report key: 1666389 · Received April 19, 2010

    Report

    Report Number
    MW5015648
    Event Type
    Injury
    Date Received
    April 19, 2010
    Date of Event
    April 12, 2010
    Report Date
    April 19, 2010
    Manufacturer
    KCI, INC
    Product Code
    OMP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B) (6) MAN, WITH FOURNIER'S GANGRENE WHO UNDERWENT MULTIPLE PERINEAL DEBRIDEMENTS FOLLOWED BY PLACEMENT OF A WOUND VAC -KCI PRODUCT-. HIS WOUND VAC WAS REMOVED BY THE PT IN AN AGITATED STATE AND THE SPONGE WAS UNINTENTIONALLY RETAINED FOR SEVERAL WEEKS -PLACED (B) (6) 2010, REMOVED (B) (6) 2010-. THE WOUND VAC SPONGES ARE NOT RADIO-OPAQUE, MAKING RECOGNITION OF RETAINED SPONGES DIFFICULT IN SOME PTS/WOUNDS. DATES OF (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: OPEN PERINEAL WOUND. MULTIPLE PERINEAL DEBRIDEMENTS: (B) (6) 2010, WITH WOUND VAC APPLICATION DURING THE 5 PROCEDURES. THE WOUND VAC SPONGE WAS INTENDED TO BE REMOVED ON (B) (6) 2010, BUT WAS UNINTENTIONALLY NOT REMOVED UNTIL (B) (6) 2010. COULD HAVE BEEN IDENTIFIED SOONER IF WAS RADIO-OPAQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KCI WOUND VAC WOUND VAC OMP KCI, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| S