BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OWENS AND MINOR, INC. MEDICHOICE TOURNIQUET

    MDR report key: 3224767 · Received July 1, 2013

    Report

    Report Number
    1649245-2013-00001
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 30, 2013
    Manufacturer
    AVCOR HEALTH CARE PRODUCTS, INC.
    Product Code
    GAX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO UF/IMPORTER REPORT (B)(4) REPORT FILED THE BRAND NAME AS AVC X-TOURN WHEN, IN FACT, THE CATALOGUE NUMBER INDICATED (TRN1184) IS AN OWENS AND MINOR, INC. MEDICHOICE LABELED MEDICAL DEVICE (PART OF OWENS AND MINOR, INC MAINSTREAM PROGRAM TO THE BEST OF OUR KNOWLEDGE). THE AVCOR CONTACT INFO (INCLUDING NAME, E-MAIL, WEB-SITE, TELEPHONE / FAX NUMBERS, ETC.) DOES NOT APPEAR ON ANY OF THE MEDCHOICE LABELING, INSERTS, ETC. THIS SCENARIO DOES NOT FOLLOW DOCUMENTATION LOGIC, I.E. CAPITAL REGION MED CTR WOULD NOT HAVE KNOWN ABOUT AVCOR; THE LACK OF CORRELATION BETWEEN THE BRAND NAME AND CATALOGUE NUMBER. AVCOR WILL CONTINUE TO PURSUE GETTING THE DEVICE IN QUESTION BACK FOR INVESTIGATORY PURPOSES. IF THE DEVICE IN QUESTION IS RECEIVED BY AVCOR AND INVESTIGATION WILL ENSUE AND THIS MEDICAL DEVICE REPORT 1649245-2013-00001 WILL BE SUMMARILY UPDATED. AVCOR WILL SEEK TO ACQUIRE AS MUCH INFO AS POSSIBLE TO BRING CLOSURE TO THIS MEDWATCH REPORT 1649245-2013-00001. IT IS IMPORTANT TO NOTE THAT THE DATE OF THE INCIDENT WAS (B)(6) 2013, THE DATE OF THE REPORT BY (B)(6) IS (B)(6) 2013, THE DATE THAT THE REPORT WAS SENT TO THE FDA IS INDICATED AS 06/XX/2013. AVCOR RECEIVED REPORT # (B)(4) ON 06/28/2013 AND FILED A REPORT WITH THE FDA POST MARKED ON 07/01/2013.

    Description of Event or Problem · 1

    ONE PT INVOLVED. PT IDENTIFIER - MARKED CONFIDENTIAL. ON 06/28/2013, UF/IMPORTER REPORT (B)(4) FILED WITH THE FDA ON (B)(4) 2013, WAS RECEIVED BY AVCOR AT THE ABOVE MENTIONED (B)(4)ADDRESS. (B)(4), OFFICIAL CORRESPONDENT TO AVCOR, WAS CONTACTED AND THEN INQUIRED WITH AVCOR FOR MORE INFO CONCERNING THIS REPORT ON 06/29/2013. THIS RESPONSE BY AVCOR, DATED ON 06/30/2013, WILL BE MAILED TO THE FDA ON 07/01/2013 BY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297306 OWENS AND MINOR, INC. MEDICHOICE TOURNIQUET TOURNIQUET GAX AVCOR HEALTH CARE PRODUCTS, INC. TRN1184 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other