BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPIOS PERICARDIUM MEMBRANE

    MDR report key: 6556853 · Received May 10, 2017

    Report

    Report Number
    3002924436-2017-00010
    Event Type
    Injury
    Date Received
    May 10, 2017
    Date of Event
    November 10, 2016
    Report Date
    August 8, 2017
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    NPL
    PMA / PMN Number
    K073097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THERE WAS ONE DEPARTURE NOTED DURING RECORDS REVIEW FOR THE RELATED STERILIZATION BATCH THE BIOBURDEN ACTION LIMIT FOR THE NACL SOLUTION WAS EXCEEDED. AT THAT TIME, TISSUE SAMPLES WERE OBTAINED FOR ALL AFFECTED TUTOPLAST PREPARATIONS AND BIOBURDEN WAS TESTED. ALL RESULTS MET REQUIREMENTS. RTI/TMI HAS DISTRIBUTED A TOTAL OF 155 GRAFTS SPECIFIC TO COPIOS PERICARDIUM MEMBRANES WITHOUT RELATED COMPLAINTS FOR THE LOT (NZ151160015). CONCLUSION: GIVEN THE FACTS THAT: THE XENOGRAFT UNDERWENT A VALIDATED STERILIZATION METHODOLOGY; TUTOPLAST®, WHICH INCLUDES TERMINAL STERILIZATION BY GAMMA IRRADIATION AFTER FINAL PACKAGING; SERIAL (B)(4) MET RTI/TMI'S SPECIFICATIONS AND RELEASE CRITERIA PRIOR TO DISTRIBUTION; THERE ARE NO RELATED COMPLAINTS ASSOCIATED WITH XENOGRAFTS DISTRIBUTED FROM THE LOT; THE SYMPTOMS EXPERIENCED BY THE PATIENT ARE EXPECTED FOR THIS KIND OF SURGERY, AND NO INFECTION WAS DOCUMENTED, IT IS MORE PLAUSIBLE THE PATIENT'S SYMPTOMS WAS ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE XENOGRAFT IMPLANT.

    Additional Manufacturer Narrative · 1

    RTI/TMI WILL CONDUCT A RE-REVIEW OF THE PRODUCT HISTORY RECORD FOR COPIOS PERICARDIUM MEMBRANES, PACKAGING PRODUCTION RECORDS, ENVIRONMENTAL MONITORING, DISTRIBUTION FOR RELATED COMPLAINTS ASSOCIATED TO THE LOT. A FOLLOW-UP MED WATCH WILL BE SUBMITTED. IMPLANTED NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016 A PUROS PI BLOCK AND CANCELLOUS PARTICULATES AND A COPIOS PERICARDIUM MEMBRANE WAS IMPLANTED FOR A DENTAL PROCEDURE WITH THE FOLLOW UP TREATMENT HE NOTICED DEHISCENCE OF SUTURE IN THE GRAFTED AREA, EVEN THOUGH THERE WAS NO INFECTION. THE BLOCK IS STILL IN ITS PLACE BUT HE WANTED TO REPORT THE DELAYED WOUND HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339394 COPIOS PERICARDIUM MEMBRANE PERICARDIUM MEMBRANE , PRODUCT CODE NPL NPL TUTOGEN MEDICAL GMBH NZ15160015

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other