BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMGRAFT

    MDR report key: 4098151 · Received September 5, 2014

    Report

    Report Number
    2028403-2014-00002
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ORGANOGENESIS, INC.
    Product Code
    PFC
    PMA / PMN Number
    P003600
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE THREE SUSPECTED INFECTIONS WERE CULTURED AND WITH POSITIVE RESULTS. DR. (B)(6) DID NOT HAVE THE RESULTS OF THE CULTURING TO REPORT WHAT ORGANISM(S) WERE IDENTIFIED. ALL THREE PATIENTS DID PRESENT WITH THE SIGNS AND SYMPTOMS OF INFECTION. ALL THREE PATIENTS WERE GIVEN APPROPRIATE ANTIBIOTICS AND FURTHER DG TREATMENT WAS DELAYED. THE THREE PATIENTS WITH THE SUSPECTED INFECTIONS RETURNED FOR A 1 WEEK FOLLOW-UP AND THEY WERE ALL RESPONDING WELL TO THE ANTIBIOTICS THAT WERE PRESCRIBED. DR. (B)(6)'S PLAN IS TO RESUME DG TREATMENT WITH EACH OF THESE PATIENTS UPON RECEIPT OF REPLACEMENT DG UNITS. THE AVAILABLE INFORMATION FOR THIS MEDICAL EVENT WAS REVIEWED BY DR (B)(4), ORGANOGENESIS INC. ON (B)(4) 2014. THE INFECTIONS CONFIRMED VIA CULTURE AT THE TREATING SITE REQUIRED INTERVENTION AS ANTIBIOTICS WERE PRESCRIBED. FROM THE INFORMATION PROVIDED, IT IS UNCLEAR WHAT CAUSED THE SIGNS AND SYMPTOMS ASSOCIATED WITH INFECTION OR IF THE MICROORGANISMS WERE ALREADY PRESENT IN THE DIABETIC ULCER PRE TREATMENT. DR (B)(6) REPORTED THAT 1 WEEK FOLLOWING AN ANTIBIOTICS REGIMEN, THAT ALL THREE PATIENTS IMPROVED AND HE STATED THEY "RESPONDED WELL TO THE ANTIBIOTIC."

    Description of Event or Problem · 1

    THIS MDR IS BEING SUBMITTED FOR PATIENT 2 OF 3 FOR THIS COMPLAINT. ON (B)(4) 2014, (B)(4), ORGANOGENSIS TISSUE REGENERATION SPECIALIST (TRS) REPORTED TO (B)(6), ORGANOGENSIS MEDICAL SCIENCE LIAISON (MSL), ON BEHALF OF THE TREATING PHYSICIAN AT THE (B)(6), THAT PATIENTS WHO WERE TREATED WITH DERMGRAFT (DG) APPLICATIONS HAD SUSPECTED INFECTIONS. SUBSEQUENT FOLLOW UP BY (B)(6), ON (B)(6) 2014 DETERMINED THAT THREE (2) SUSPECTED INFECTIONS WERE OBSERVED. EACH WAS ACCOMPANIED WITH A FOUL ODOR AND INCREASED DRAINAGE WHEN SUBJECTS CAME IN FOR THEIR ONE-WEEK FOLLOW-UP APPOINTMENTS ON (B)(6) 2014. DR (B)(6) WAS SKEPTICAL TO CONTINUE USING THIS LOT AS HE THOUGH IT WAS POSSIBLE THAT DG CAUSED THE PRESENTATION OF INFECTIONS. EACH OF THESE PATIENTS WAS TREATED WITH ONE (1) DG FOR THE TREATMENT OF DIABETIC FOOT ULCERS. THESE UNITS WERE FROM DG LOT #147049, UNIT NUMBERS UNKNOWN, AND EXPIRATION DATE OCTOBER 10, 2014. BASED ON THE DESCRIPTION OF THE INFECTIONS AND THE POSITIVE RESPONSE TO ANTIBIOTICS, THE SEVERITY OF THESE EVENTS MAY BE CONSIDERED AS MODERATE. THIS LOT WAS SHIPPED TO 280 SITES WITHOUT A SINGLE ADDITIONAL COMPLAINT. ALL MANUFACTURING AND TESTING DOCUMENTATION WAS REVIEWED AND NO ATYPICAL EVENTS WERE RECORDED THAT MIGHT EXPLAIN THE INFECTIONS OBSERVED. THE NEGATIVE STERILITY TEST RESULTS ON THE RETAIN SAMPLES VALIDATED THAT THE INTEGRITY OF THE PRODUCT REMAINED FREE FROM MICROORGANISMS AS IT WAS IN THE ORGANAL RELEASE. A POTENTIAL ROOT CAUSE OF THE INFECTION COULD BE FORM A PREEXISTING MICROBIAL CONTAMINATION OF THE WOUND BED. ANOTHER POTENTIAL ROOT CAUSE OF THIS EVENT WOULD BE IF THESE UNITS WERE CONTAMINATED BY A COMMON CAUSE DURING THAWING RINSING OR APPLICATION AT THE (B)(6) SITE. ALTHOUGH THERE IS SUBSTANTIAL EVIDENCE TO SUPPORT THAT THE USE OF DG IS UNLIKELY THE CAUSE OF INFECTIONS, RELATEDNESS CANNOT BE COMPLETELY RULED OUT FOR THESE 3 APPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543712 DERMGRAFT PFC ORGANOGENESIS, INC. 147049

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other