BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND PRS 8 CM X 16 CM SEM

    MDR report key: 11455854 · Received March 10, 2021

    Report

    Report Number
    3004170064-2021-00002
    Event Type
    Injury
    Date Received
    March 10, 2021
    Report Date
    March 26, 2021
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K071807
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SURGIMEND (PRODUCT ID 606-004-103) WAS NOT RETURNED FOR EVALUATION (REMAINS IN PATIENT); 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. HOWEVER, AN IMAGE WAS PROVIDED SHOWING BREAKAGE/TEAR OF IMPLANTED PRODUCT. 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

    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

    A SURGEON REPORTED THE SURGIMEND HAD SPLIT AT THE FENESTRATIONS - IN BOTH BREASTS - AND THE IMPLANT WAS GAPING THROUGH. HE COMPLETED A BILATERAL NIPPLE-SPARING RISK-REDUCING MASTECTOMY USING BILATERAL SURGIMEND. THE PATIENT IS A (B)(6) YEAR-OLD FEMALE WITH NO RISK FACTORS. APPROXIMATELY TWO WEEKS AFTER SURGERY HE HAD TO TAKE THE PATIENT BACK TO THE OPERATING ROOM DUE TO SUDDEN PAIN OVER HER LEFT RECONSTRUCTION. HE DID NOT FIND TOO MUCH BUT HE WASHED OUT HER IMPLANT CAVITY AND REPLACED HER DRAIN. WHILE SHE WAS IN HOSPITAL ON INTRAVENOUS ANTIBIOTICS, THE OTHER SIDE BECAME RED AND TENDER. ONCE AGAIN HE TOOK HER BACK TO THE OPERATING ROOM AND ONCE AGAIN FOUND NO INFECTION. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, THE PATIENT IS MAKING A GOOD RECOVERY. BESIDES PAIN, THERE IS A WORKING DIAGNOSIS OF BILATERAL PERI-PROSTHETIC INFECTION - WHICH IS UNUSUAL IN THE ABSENCE OF RISK-FACTORS AS WELL AS GIVEN SHE DEVELOPED A CONTRALATERAL INFECTION WHILST ON IV ANTIBIOTICS. PATIENT'S WHITE COUNT WAS HIGH PRIOR TO HER LEFT SIDED EXPLORATION (ON FEB 9TH) AND SHE HAD A MILD TACHYCARDIA - ALTHOUGH SHE DID NOT HAVE MUCH IN THE WAY OF PERIPROSTHETIC FLUID DURING EITHER EXPLORATION. SHE DID HAVE SOME ERYTHEMA OVER THE RIGHT SIDE PRE-EXPLORATION (ON FEB 12TH) BUT NOT OVER THE LEFT. THE MICRO SWAB FROM THE RIGHT SIDE GREW 1+ OF S. AUREUS - SO NOT A HEAVY CONTAMINATION. WEIRDLY, SHE WAS INITIALLY TREATED WITH IV CEFAZOLIN FOR HER LEFT SIDED EXPLORATION BUT DEVELOPED THE RIGHT SIDED INFECTION WHILST ON THESE ANTIBIOTICS. SHE WAS THEREFORE STEPPED UP TO PIP-TAZO AND VANCO AFTER THE RIGHT SIDED EXPLORATION. SO ALL IN ALL IT IS DIFFICULT TO KNOW EXACTLY WHAT THE IDEOLOGY OF HER ACUTE ISSUES WERE. THE WORKING DIAGNOSIS IS INFECTION, ALTHOUGH THIS HAS SOME VERY ATYPICAL CHARACTERISTICS - INCLUDING THE APPEARANCE OF THE SURGIMEND MESH BILATERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350299 SURGIMEND PRS 8 CM X 16 CM SEM SURGIMEND FTM TEI BIOSCIENCES INC 1905021

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR