BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMAGRAFT

    MDR report key: 2312386 · Received October 26, 2011

    Report

    Report Number
    0002028403-2011-00038
    Event Type
    Other
    Date Received
    October 26, 2011
    Date of Event
    September 25, 2011
    Report Date
    September 27, 2011
    Manufacturer
    ADVANCED BIOHEALING, INC.
    Product Code
    MGR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT WAS IN THE TREATED GROUP DURING PROTOCOL #(B)(4), AND RECEIVED 8 APPLICATIONS OF DERMAGRAFT, THE LAST OF WHICH WAS (B)(6) MONTHS PRIOR TO THIS SERIOUS ADVERSE EVENT. THE SUBJECT WAS IN THE NON-TREATED GROUP DURING PROTOCOL #(B)(4). THE INVESTIGATOR DEEMED THE SERIOUS ADVERSE EVENT UNRELATED TO THE PT'S PARTICIPATION IN THE (B)(4) STUDY. ADDITIONAL LOT NUMBERS: 132705, 133065. ADDITIONAL EXPIRATION DATES: 11/21/2010, 12/22/2010. ADDITIONAL MANUFACTURE DATES: 05/2010, 06/2010.

    Description of Event or Problem · 1

    THE SUBJECT MISSED A SCHEDULED APPOINTMENT ON (B)(6) 2011. A VOICE MAIL WAS LEFT TO CALL THE OFFICE DUE TO THE MISSED VISIT. HE CALLED BACK AND SAID HE WAS IN THE HOSPITAL AND HAD BEEN TAKEN TO THE HOSPITAL BY AMBULANCE. HE SAID THAT HE HAD "BLANKED OUT" ON (B)(6) 2011. HE REPORTS THAT HE HAD NO SIGNS OR SYMPTOMS PRIOR TO THE EVENT, BUT WAS TOLD THAT HE HAD A SEIZURE. UPON FURTHER EVALUATION AT THE HOSPITAL, HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH GLUCOSE. SYMPTOMS RESOLVED. HE WAS DISCHARGED ON (B)(6) 2011, WITH INSTRUCTIONS TO FOLLOW-UP WITH HIS MEDICAL DOCTOR. THE SUBJECT SAW HIS DOCTOR ON (B)(6) 2011, WHO CHANGED THE WARFARIN TO 7.5MG QD X 5 DAYS AND 5MG QD X 2 DAYS. HE WAS INSTRUCTED TO SEE A CARDIOLOGIST AND NEUROLOGIST AND RETURN TO HIS MEDICAL DOCTOR IN ONE MONTH. THE SUBJECT WAS IN THE TREATED GROUP DURING PROTOCOL #(B)(4), AND RECEIVED 8 APPLICATIONS OF DERMAGRAFT, THE LAST OF WHICH WAS 12 MONTHS PRIOR TO THIS SAE. HE WAS IN THE NON-TREATED GROUP DURING PROTOCOL #(B)(4). THE INVESTIGATOR DEEMED THE SERIOUS ADVERSE EVENT UNRELATED TO THE PT'S PARTICIPATION IN THE (B)(4) STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL SUBST. MGR ADVANCED BIOHEALING, INC. 11045 132142

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization BENAZEPRIL 20 MG QD| WARFARIN 15 MG QD 4 X PER WEEK| ALEVE 220 MG PRN| TYLENOL 500 MG PRN| ASPIRIN 81 MG QA| PLAVIX 75 MG QD| WARFARIN 10 MG QD 3 X PER WEEK| CENTRUM SILVER QD| VERAPAMIL 240MG QD