BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVINE PERICARDIUM MEMBRANE

    MDR report key: 7290445 · Received February 22, 2018

    Report

    Report Number
    3002924436-2018-00001
    Event Type
    Injury
    Date Received
    February 22, 2018
    Report Date
    January 18, 2019
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    NPL
    PMA / PMN Number
    K073097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE PRODUCT IDENTIFIERS WERE NOT PROVIDED, THEREFORE A COMPLETE INVESTIGATION INCLUDING MANUFACTURING RECORDS REVIEW COULD NOT BE CONDUCTED. IN PRINCIPLE, THE BOVINE MATERIAL COULD HAVE CAUSED AN ALLERGIC REACTION. SKIN SYMPTOMS MAY ALSO INDICATE INFLAMMATION. ADDITIONAL INFORMATION IS NEEDED IN ORDER TO DETERMINE THE CAUSE OF THE ALLERGIC REACTION.

    Description of Event or Problem · 0

    RTI SURGICAL, INC (RTI) AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY OWNED SUBSIDIARY OF RTI, HAVE NOT RECEIVED ANY ADDITIONAL INFORMATION FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    PRODUCT IDENTIFIERS HAVE NOT BEEN PROVIDED AT THIS TIME. RTI/TMI WILL CONDUCT AN INVESTIGATION OF HTE PRODUCT HISTORY FOR BOVINE PERICARDIUM MEMBRANES, PACKAGING PRODUCTION RECORDS, ENVIRONMENTAL MONITORING AND DISTRIBUTION INFORMATION FOR RELATED COMPLAINT ASSOCIATED WITH THE LOT, ONCE THE UNIQUE IDENTIFIERS ARE PROVIDED.

    Description of Event or Problem · 1

    RTI SURGICAL, INC (RTI) AND TUTOGEN MEDICAL(B)(4)A WHOLLY OWNED SUBSIDIARY OF RTI, RECEIVED A COMPLAINT ON (B)(6) 2018. THE COMPLAINT INDICATED THAT A PATIENT WAS IMPLANTED WITH A BOVINE PERICARDIUM MEMBRANE ON (B)(6) 2017 AND LATER DEVELOPED SKIN SYMPTOMS THAT POINTED TOWARDS AN ALLERGIC REACTION (UNKNOWN DATE OF ONSET). ON (B)(6) 2018, THE COMPLAINT COORDINATOR FOR THE DISTRIBUTOR CALLED THE ALLERGIST THAT EVALUATED THE PATIENT, WHO INDICATED THAT THE BOVINE PERICARDIUM DID NOT CAUSE THE ALLERGIC REACTION. PRODUCT IDENTIFIERS WERE NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133345 BOVINE PERICARDIUM MEMBRANE DENTAL PERICARDIUM MEMBRANE NPL TUTOGEN MEDICAL GMBH NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other