BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DVT FOOT GARMENTS

    MDR report key: 3034392 · Received March 29, 2013

    Report

    Report Number
    3007420694-2013-00015
    Event Type
    Injury
    Date Received
    March 29, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION ((B)(4)) BY ARJOHUNTLEIGH, INC. ((B)(4)) ON BEHALF OF THE MANUFACTURER (ARJOHUNTLEIGH POLSKA SP. ZO.O) (3007420694). MANUFACTURER'S COMPLAINT NUMBER REF: (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    POTENTIAL INCIDENT - PER THE AHUS SALES AE: "BARIATRIC PT DEVELOPED A PE POST OP. THE PT WAS TOO LARGE FOR THE DVT/60 SLEEVE AND HAD TO USE THE FG200 FOOT GARMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130427 DVT FOOT GARMENTS DVT JOW ARJOHUNTLEIGH POLSKA SP. ZO.O. FG200

    Patients

    Seq Age Sex Outcome Treatment
    1