BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND MP 10 CM X 15 CM X 2MM

    MDR report key: 12662268 · Received October 19, 2021

    Report

    Report Number
    3004170064-2021-00010
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    September 29, 2021
    Report Date
    March 23, 2022
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K162965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: CONSEQUENCES FOR THE PATIENT : SUSPICION OF ALLERGY WHICH WAS RULED OUT AFTER SKIN ALLERGY TESTING SURGIMEND WAS IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, DIAGNOSIS OF PERICARDITIS BY PLEURAL EFFUSION WHICH RAISES THE SUSPICION OF AN ALLERGIC REACTION TO THE PROSTHESIS AGE OF PATIENT : ADULT. SYMPTOMS OF PATIENT : SKIN ALLERGY REACTION LOCATED ON ABDOMEN. TREATMENT : DRAINAGE AND REMOVAL OF SURGIMEND. TEST WITH ANOTHER SURGIMEND UNIT WAS DONE. RESULTS DID NOT INDICATE ALLERGY WITH UNIT UNDERLYING MEDICAL CONDITIONS OF PATIENT REGARDING ALLERGY : ALLERGY OF WASP VENOM AND URTICARIA WITH BREXIN (NONSTEROIDAL ANTI-INFLAMMATORY DRUGS). IT IS UNKNOWN HOW THE PATIENT IS DOING NOW.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ALLERGIST SUSPECTED ALLERGIC REACTION WITH THE USE OF SURGIMEND TO TREAT AN HIATAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559766 SURGIMEND MP 10 CM X 15 CM X 2MM SURGIMEND FTM TEI BIOSCIENCES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male