BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX AND SILICONE SL FOLEY SWIVEL SILICONE TRICOT

    MDR report key: 3784291 · Received April 24, 2014

    Report

    Report Number
    1018233-2014-00086
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    March 31, 2014
    Manufacturer
    DAVOL SURGICAL INNOVATIONS
    Product Code
    EYJ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER WAS NOT PROVIDED THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A SORE AS A RESULT OF USING THE DEVICE. THE PATIENT HAD BEEN USING THE DEVICE FOR SEVERAL MONTHS PRIOR TO THIS EVENT. THE INJURY IS REQUIRING A PRIMARY DRESSING EVERY TWO DAYS. THE DEVICE WAS IN PLACE FOR 6 DAYS. IT WAS REMOVED WITHOUT THE USE OF ALCOHOL GEL. THE PLACEMENT OF PREVIOUS DEVICES WAS ALTERNATED BETWEEN LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248420 LATEX AND SILICONE SL FOLEY SWIVEL SILICONE TRICOT EYJ DAVOL SURGICAL INNOVATIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention