BEUDAMED
    FDA Adverse Event Death Summary report: N

    DERMAGRAFT

    MDR report key: 2474401 · Received January 20, 2012

    Report

    Report Number
    2028403-2012-00003
    Event Type
    Death
    Date Received
    January 20, 2012
    Report Date
    December 6, 2011
    Manufacturer
    ADVANCED BIOHEALING, INC.
    Product Code
    MGR
    PMA / PMN Number
    P000036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVASIVE GROUP A STREPTOCOCCAL INFECTIONS ARE ASSOCIATED WITH HIGH RATES OF MORBIDITY AND MORTALITY AND ALSO WITH A SUBSTANTIAL RISK OF TRANSMISSION IN HEALTH CARE INSTITUTIONS, WHERE CROSS-TRANSMISSION IS COMMON. PTS WHO ARE ELDERLY OR HAVE UNDERLYING MEDICAL CONDITIONS (INCLUDING CARDIOVASCULAR DISEASE, DIABETES, SKIN BREAKDOWN, STEROID EXPOSURE AND MALIGNANCY) ARE AT GREATEST A PRIORI RISK FOR DEVELOPING SUCH INFECTIONS, AND OLDER PTS HAVE THE HIGHEST INCIDENCE AND CASE FATALITY RATE. (DAVIES 1996; DANEMAN 2005; THIGPEN 2007). ON THE BASIS OF THE CURRENTLY AVAILABLE INFORMATION, ABH CONSIDERS THE REPORTED CLUSTER OF STREPTOCOCCAL INFECTIONS TO BE UNRELATED TO ANY FAILURE, MALFUNCTION OR MANUFACTURING PROCESS INVOLVING DERMAGRAFT. ABH HAS IDENTIFIED ALL LOTS OF DERMAGRAFT APPLIED TO THE PTS, AND ALL LOTS PASSED STERILITY AS PART OF RELEASE TESTING. REPEAT STERILITY TESTING WAS CONDUCTED ON THE RETENTION SAMPLES FOR THESE LOTS TO PROVIDE ADDITIONAL ASSURANCE OF PRODUCT QUALITY, AND ALL TEST RESULTS WERE AGAIN NEGATIVE (PASS). IN ADDITION, ABH HAS NO REPORTS OF OTHER INFECTIONS INVOLVING GROUP A STREP ORGANISMS ASSOCIATED WITH ANY OF THE IDENTIFIED LOTS, OR ANY OTHER LOTS OF DERMAGRAFT, DURING THIS PERIOD. THE FACTS THAT THE CONFIRMED GROUP A STREP INFECTIONS ARE CONFINED TO ONE GEOGRAPHIC AND INSTITUTIONAL LOCATION, AND THAT AT LEAST ONE INFECTION INVOLVED A PT WHO DID NOT RECEIVE DERMAGRAFT, BOTH ARGUE FOR AN INFECTION SOURCE SPECIFIC TO THAT LOCATION AND POSSIBLY ITS TREATMENT PROCEDURES, AND NOT RELATED TO THE GRAFT ITSELF. DAVIES HD, MCGEER A, SCHWARTZ B, ET AL. INVASIVE GROUP A STREPTOCOCCAL INFECTIONS IN ONTARIO, CANADA. ONTARIO GROUP A STREPTOCOCCAL STUDY GROUP. N ENGL J MED. 1996 AUG 22;335(8):547-54. DANEMAN N, MCGEER A, LOW DE, ET AL. HOSPITAL-ACQUIRED INVASIVE GROUP A STREPTOCOCCAL INFECTIONS IN ONTARIO, CANADA, 1992-2000. CLIN INFECT DIS. 2005 AUG 1;41(3):334-42. THIGPEN MC, RICHARDS CL JR, LYNFIELD R, ET AL. INVASIVE GROUP A STREPTOCOCCAL INFECTION IN OLDER ADULTS IN LONG-TERM CARE FACILITIES AND THE COMMUNITY, UNITED STATES, 1998-2003. EMERG INFECT DIS. 2007 DEC; 13(12):1852-9.

    Description of Event or Problem · 1

    DEATH [DEATH], STREPTOCOCCAL INFECTION [STREPTOCOCCAL INFECTION]. CASE DESCRIPTION: THIS CASE IS IN FOLLOW-UP TO MANUFACTURER REPORT #2028403-2011-00039 ORIGINALLY SUBMITTED ON 08DEC2011 AS ONE REPORT DESCRIBING THE INITIAL INFORMATION FOR 12 PTS FROM A SINGLE SITE. INITIAL INFORMATION WAS RECEIVED ON 16NOV2011 (SALE REPRESENTATIVE, INITIAL NOTIFICATION WITH NO DETAILS) AND 06DEC2011 (TELEPHONE CONVERSATION WITH SITE AND INITIAL STERILITY RESULTS). THIS INFORMATION WAS IN THE ORIGINAL SUBMISSION ON 08DEC2011. FOLLOW-UP INFORMATION WAS RECEIVED AND INCLUDED IN THIS REPORT ON 16JAN2012 (EMAIL FROM SITE). ON 16NOV2011, ABH RECEIVED INFORMATION VIA A SALES REPRESENTATIVE, INDICATING THAT SEVERAL GROUP A STREPTOCOCCAL INFECTIONS HAD BEEN IDENTIFIED AS HAVING OCCURRED IN DIABETIC PODIATRIC PTS TREATED WITH DERMAGRAFT AT A SINGLE OUTPATIENT FACILITY EARLIER THIS YEAR. ON 06DEC2011, ABH FOLLOWED UP DIRECTLY WITH THE SITE, WHO INDICATED THAT SUCH INFECTION IN A TOTAL OF 12 PTS, ALL OF WHOM WERE SUBSEQUENTLY TREATED AT SAME HOSPITAL FACILITY AND THAT FOUR OF THESE PTS HAD DIED (THE DEATHS OCCURRING (B)(6)). ACCORDING TO THE INFORMATION PROVIDED BY THE INPATIENT FACILITY, 4 OF THE 12 WHO HAD RECEIVED DERMAGRAFT EXPERIENCED ONLY LEG WOUND INFECTIONS AND ANOTHER 8 HAD POSITIVE BLOOD CULTURES. THE FACILITY DISCLOSED THAT MOST OF THESE 12 PTS, INCLUDING ALL 4 WITH FATAL OUTCOMES, WERE ELDERLY AND HAD MULTIPLE UNDERLYING SEVERE CO-MORBIDITIES, BUT HAS DECLINED REPEATED REQUESTS FOR ADDITIONAL PT INFORMATION, INCLUDING THE RELATIONSHIP IF ANY BETWEEN THE INFECTIONS AND THE FATAL OUTCOMES. ALL 12 OF THESE PTS HAD DERMAGRAFT APPLIED AT LEAST ONCE, AND MOST HAD MULTIPLE APPLICATIONS. (OF NOTE, HOWEVER, IS THAT AN ADDITIONAL GROUP A STREP INFECTION WAS ALSO IDENTIFIED IN A NON-PODIATRIC PT WHO HAD NOT RECEIVED DERMAGRAFT.) THE EXACT LOT(S) PER PTS TREATED IS NOT KNOWN, BUT BELOW IS A TABLE SHOWING LOT INFORMATION USED BY THE SITE ACROSS ALL 12 PTS. ADDITIONAL LOT NUMBER: 136166, ADDITIONAL EXPIRATION DATE: 19-SEP-2011, ADDITIONAL MANUFACTURE DATE: 19-MAR-2011; 136251, 23-SEP-2011, 23-MAR-2011; 136073, 08-SEP-2011, 08-MAR-2011; 136328, 29-SEP-2011, 29-MAR-2011; 136426, 06-OCT-2011, 06-APR-2011; 136870, 17-NOV-2011, 17-MAY-2011; 136743, 11-NOV-2011, 11-MAY-2011; 136502, 11-OCT-2011, 11-APR-2011; 136505, 14-OCT-2011, 14-APR-2011; 136657, 28-OCT-2011, 28-APR-2011; 136898, 23-NOV-2011, 23-MAY-2011; 136742, 10-NOV-2011, 10-MAY-2011; 135943, 03-SEP-2011, 03-MAR-2011; 137178, 15-DEC-2011, 15-JUN-2011; 137064, 03-DEC-2011, 03-JUN-2011; 137180, 17-DEC-2011, 17-JUN-2011; 137243, 20-DEC-2011, 20-JUN-2011. ALTHOUGH ABH HAS MADE SEVERAL ATTEMPTS (20-DEC-2011 VIA TELECONFERENCE; 04JAN2012 VIA CERTIFIED LETTER; AND 16JAN2012 VIA EMAIL) TO OBTAIN ADDITIONAL PT INFORMATION ON ALL 12 PTS, THE SITE HAS NOT AND DOES NOT INTEND TO PROVIDE ABH WITH ANY ADDITIONAL INFORMATION. THE CHIEF OF STAFF FROM THE SITE INDICATED IN HIS EMAIL DATED 16JAN2012, THAT THEIR INVESTIGATION FOUND NO ISSUE WITH OUR PRODUCT. THE SITE IS REVIEWING THEIR CURRENT PROCESSES AND PLANS TO RESUME THE USE OF DERMAGRAFT ONCE REVIEW IS COMPLETED AND ARE CONFIDENT THEY HAVE THE APPROPRIATE SYSTEMS IN PLACE. ABH HAS IDENTIFIED ALL LOTS OF DERMAGRAFT APPLIED TO THE PTS. ALL LOTS PASSED STERILITY AS PART OF RELEASE TESTING. REPEAT STERILITY TESTING WAS CONDUCTED ON THE RETENTION SAMPLES FOR THESE LOTS TO PROVIDE ADDITIONAL ASSURANCE OF PRODUCT QUALITY AND ALL TEST RESULTS WERE NEGATIVE (PASS). IN ADDITION, ABH HAS NO REPORTS OF OTHER INFECTIONS INVOLVING GROUP A STREP ORGANISMS ASSOCIATED WITH ANY OF THE IDENTIFIED LOTS, OR ANY OTHER LOTS OF DERMAGRAFT, DURING THIS PERIOD. BASED ON THE ABOVE INFORMATION, ABH DOES NOT DEEM THESE INFECTIONS AND DEATHS TO BE RELATED TO DERMAGRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE MGR ADVANCED BIOHEALING, INC. 11045 136076

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R