BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APLIGRAF

    MDR report key: 3946448 · Received July 11, 2014

    Report

    Report Number
    1221816-2014-00001
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    April 4, 2013
    Report Date
    July 11, 2014
    Manufacturer
    ORGANOGENESIS, INC.
    Product Code
    MGR
    PMA / PMN Number
    BP953200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    APLIGRAF LOT# GS1302.21.01.1A (UNIT # 75) WAS PACKAGED ON 03/19/2013 AND TRANSFERRED TO SHIPPING ON 03/19/2013. THE LOT MET ALL SPECIFICATIONS AND RELEASE CRITERIA FOR SHIPMENT. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT INDICATED THAT ALL REQUIRED DOCUMENTATION AND REVIEW SIGNATURES WERE COMPLETED PRIOR TO TRANSFER OF THE LOT TO SHIPPING. HISTOLOGY SAMPLES FROM THIS LOT MET DEVICE SPECIFICATIONS AT 12 DAYS POST AIRLIFT (03/15/2013) AND HISTOLOGY TESTING DOCUMENTATION WAS REVIEWED BY QA ON 03/18/2013. ALL FINAL STERILITY AND MYCOPLASMA RESULTS WERE NEGATIVE. ADDITIONALLY, ENDOTOXIN TESTING RESULTS PASSED. THE LOT MET ALL SPECIFICATIONS AND RELEASE CRITERIA FOR SHIPMENT.

    Description of Event or Problem · 1

    ON (B)(4) 2013, (B)(4), QUALITY ASSURANCE COMPLIANCE SPECIALIST, ORGANOGENESIS INC. (OI), WAS NOTIFIED VIA TELEPHONE BY (B)(6), TISSUE REGENERATION SPECIALIST, 01, ON BEHALF OF DR. (B)(6), DPM, (B)(6)) HOSPITAL, (B)(6), REGARDING A MALE PATIENT WHO HAD RECEIVED FIVE APLIGRAF APPLICATIONS TO HIS VLU "LEFT FOOT/ANKLE." FOLLOWING THE PATIENT'S FIFTH APLIGRAF APPLICATION ON AN UNKNOWN DATE (LOT# GS 1302.21.01.1A, UNIT #75; PRIOR APLIGRAF DATES, LOT AND UNIT NUMBERS UNKNOWN), THE PATIENT PRESENTED ON (B)(6) 2013 AND WAS OBSERVED TO HAVE A GENERALIZED RASH, ASSESSED AS A POTENTIAL ALLERGIC REACTION TO APLIGRAF. ADDITIONAL INFORMATION WAS OBTAINED FROM (B)(6), TISSUE REGENERATION SPECIALIST, 01 ON BEHALF OF DR. (B)(6), (B)(6) HOSPITAL REGARDING THE ACTUAL DIAGNOSIS AND HISTORY OF THE PRESENTING CONDITION, CO-MORBIDITIES, CONCOMITANT MEDICATIONS AND THE REPORTED EVENT OUTCOME. THIS MALE PATIENT OF UNDETERMINED AGE (INITIALS AND DATE OF BIRTH UNKNOWN/NOT REPORTED) WAS BEING TREATED BY DR. (B)(6) FOR A VENOUS LEG ULCER (VLU) ON HIS "LEFT FOOT/ANKLE" (DURATION OF WOUND NOT AVAILABLE). PER (B)(6), THE PATIENT HAD NO REPORTED RASHES FOLLOWING HIS FOUR PRIOR APLIGRAF APPLICATIONS (DATES, LOT NUMBERS AND UNIT NUMBERS UNKNOWN/NOT PROVIDED). PATIENT COMORBIDITIES, CONCOMITANT MEDICATIONS AND ALLERGY HISTORY WERE UNKNOWN/NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406965 APLIGRAF NA MGR ORGANOGENESIS, INC. GS1302.21.01.1A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O