BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIMEND 3.0 25X40 CM

    MDR report key: 10543649 · Received September 16, 2020

    Report

    Report Number
    3004170064-2020-00009
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Report Date
    March 30, 2021
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K083898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SURGIMEND (606-300-016) WAS NOT RETURNED FOR EVALUATION; HOWEVER, AN IMAGE WAS PROVIDED. THE IMAGE PROVIDED INDICATES THAT PART OF THE PRODUCT MELTED AWAY AFTER IMPLANTATION. THE INSTRUCTION FOR USE (IFU) STATES THE FOLLOWING UNDER WARNINGS AND PRECAUTIONS: ¿SURGIMEND SHOULD BE USED WITH CAUTION IN SURGICAL LOCATIONS WHERE THE PRODUCT MAY BE EXPOSED TO STOMACH AND/OR INTESTINAL CONTENTS. COLLAGEN-BASED IMPLANTS CAN BE SUSCEPTIBLE TO DEGRADATION BY DIGESTIVE ENZYMES AND CONDITIONS OF ACIDIC (LOW) PH.¿ ¿SURGIMEND SHOULD BE USED WITH CAUTION IN REGIONS WHERE THE INFECTION EXISTS OR IS SUSPECTED. TREAT ANY EXISTING INFECTION APPROPRIATELY. IF USED IN CONTAMINATED OR INFECTED WOUNDS, COLLAGEN-BASED IMPLANTS CAN WEAKEN OR BREAK DOWN¿ INTEGRA LIFESCIENCES HAS PROCEDURES IN PLACE FOR EACH PART OF THE MANUFACTURING, LABELING AND SHIPPING PROCESS TO DESCRIBE THE PROPER PROCESS STEPS AND ENSURE ALL PRODUCTS ARE SAFE AND EFFECTIVE.

    Additional Manufacturer Narrative · 0

    SURGIMEND (PRODUCT ID: 606300016) 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.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT A SURGIMEND 3.0 25X40 WAS IMPLANTED IN PATIENT ON (B)(6) 2020. THE SURGIMEND WAS USED TO TREAT AN ENTEROCUTANEOUS FISTULA FROM OLD COMPOSITE MESH. KCI VAC WITH REGULAR SETTINGS WAS USED OVER THE WOUND SITE (APPROXIMATELY 20X10CM) AFTER SURGERY. AS PER THE SURGEON, THE SURGIMEND LOOKED NORMAL AND GOOD AT FIRST WOUND CHANGE. AT SECOND WOUND CHANGE THE SURGIMEND HAD COMPLETELY DISINTEGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005004 SURGIMEND 3.0 25X40 CM SURGIMEND FTM TEI BIOSCIENCES INC 1901031

    Patients

    Seq Age Sex Outcome Treatment
    1