BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JIT TRAUMA/ ABDOMINAL PACK

    MDR report key: 4201128 · Received September 16, 2014

    Report

    Report Number
    3005011024-2014-00014
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 15, 2014
    Manufacturer
    DEROYAL LAFOLLETTE
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE QFI REPORT WAS REVIEWED TO OBTAIN THE SALES AND SIMILAR COMPLAINT INFO. DEROYAL HAS SOLD (B)(4) CASES OF THE FINISHED GOOD FROM 2012 TO 2014. THERE HAVE BEEN NO SIMILAR ISSUES FOR THE FINISHED GOOD REPORTED. THE ISSUE REPORTED IS IN REFERENCE TO STRIKETHROUGH OCCURRING ON A GOWN. THE BOM WAS REVIEWED AND IT WAS IDENTIFIED THAT TWO GOWNS ARE PRESENT WITHIN THE PACK: 5-19323- SURGICAL GOWN X-LARGE IMPERVIOUS STANDARD MICROCOOL AND 5-12564- SURGICAL GOWN X-LARGE ULTRA STANDARD NON-REINFORCED. IT IS CURRENTLY UNK AS TO WHICH GOWN THE RESIDENT SURGEON WAS WEARING. ADD'L INFO HAS BEEN REQUESTED FROM THE DEROYAL SALES REP ON (B)(6) 2014. NO FURTHER INFO IS AVAILABLE AT THIS TIME. WILL PROVIDE FOLLOW UPS IF INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE RESIDENT SURGEON HAD STRIKE THROUGH ON HANDS AND ARMS WEARING KC GOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572431 JIT TRAUMA/ ABDOMINAL PACK KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL LAFOLLETTE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R