BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1480357 · Received September 18, 2009

    Report

    Report Number
    3005147058-2009-00016
    Event Type
    Injury
    Date Received
    September 18, 2009
    Date of Event
    May 13, 2009
    Report Date
    September 9, 2009
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Product Code
    FTM
    PMA / PMN Number
    K071065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. AS A RESULT, TESTING COULD NOT BE PERFORMED. CAUSE OF THE EVENT IS UNK AT THIS TIME. ADDITIONAL INFO WAS REQUESTED FROM THE PHYSICIAN; HOWEVER, NO ADDITIONAL INFO WAS PROVIDED AT THE TIME OF THIS REPORT. THE MANUFACTURING LOT AND EXPIRATION DATE OF THE DEVICE WERE NOT PROVIDED. THE MANUFACTURER OF THE DEVICE AT THE TIME WAS PEGASUS BIOLOGICS, INC. SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC IS THE REPORTING COMPANY FOR THE EVENT. THE EVENT OCCURRED PRIOR TO SYNOVIS ACQUIRING PEGASUS BIOLOGICS.

    Description of Event or Problem · 1

    CASE WAS REPORTED AS EXPLANT OF ORTHADAPT BIOIMPLANT. CASE INFO (INCLUDING CASE TYPE OR SIGNS AND SYMPTOMS) WERE NOT PROVIDED AT TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization