BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 23705242 · Received December 3, 2025

    Report

    Report Number
    2210968-2025-13524
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    January 1, 2025
    Report Date
    December 3, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: NOT PROVIDED.

    Description of Event or Problem · 0

    TITLE: DELAYED INTRAVESICAL EROSION OF MERSILENE TAPE USED FOR CERVICAL CERCLAGE: A CASE REPORT. THE AIM OF THIS STUDY IS TO DESCRIBE CURRENT LITERATURE ON LONG-TERM SEQUELAE OF RETAINED CERVICAL CERCLAGE, FOCUSING ON URINARY TRACT COMPLICATIONS. TO PRESENT AN ILLUSTRATIVE CASE OF A PATIENT WITH BLADDER EROSION SECONDARY TO REMOTE CERVICAL CERCLAGE PLACEMENT, AND DISCUSS HER CLINICAL HISTORY, DIAGNOSTIC WORK-UP, SURGICAL MANAGEMENT AND POST-OPERATIVE COURSE. TO OUTLINE RECOMMENDATIONS FOR EVALUATION OF CHRONIC REFRACTORY BLADDER PAIN AND HIGHLIGHT SURGICAL APPROACHES TO MANAGE INTRAVESICAL RETAINED FOREIGN BODIES. A 67-YEAR-OLD FEMALE PATIENT WITH DYSURIA, URGENCY, FREQUENCY, AND INTERMITTENT HEMATURIA WHO WAS PREVIOUSLY DIAGNOSED WITH INTERSTITIAL CYSTITIS REFRACTORY TO STANDARD TREATMENT. INTRAVESICAL MERSILENE TAPE, A POLYETHYLENE TEREPHTHALATE SUTURE, WAS IDENTIFIED ON CYSTOSCOPY, AND SUPRAPUBIC-ASSISTED TRANSURETHRAL REMOVAL WITH LASER EXCISION WAS PERFORMED. THE MEAN DURATION FOLLOW-UP WAS NOT REPORTED. REPORTED COMPLICATION: MERSILENE TAPE (ETHICON): (N=1) 67-YEAR-OLD FEMALE PATIENT HAD BLADDER EROSION TREATMENT: NOT REPORTED (N=1) HAD CALCULI FORMATION TREATMENT: NOT REPORTED (N=1) HAD URINARY TRACT INFECTIONS (UTIS) TREATMENT: NOT REPORTED (N=1) PAIN TREATMENT: NOT REPORTED (N=1) HEMORRHAGE TREATMENT: NOT REPORTED (N=1) UNSPECIFIED TISSUE INJURY TREATMENT: NOT REPORTED. IN CONCLUSIONS, THE CASE UNDERSCORES THE IMPORTANCE OF CYSTOSCOPY AS PART OF THE DIAGNOSTIC EVALUATION OF PATIENTS WITH HEMATURIA, RECURRENT URINARY TRACT INFECTIONS, AND PERSISTENT LOWER URINARY TRACT SYMPTOMS AFTER INITIAL TREATMENT. EARLY SUSPICION FOR AND RECOGNITION OF RETAINED FOREIGN BODY MAY HAVE SPARED OUR PATIENT FROM UNNECESSARY PROCEDURES AND ANTIBIOTIC EXPOSURE AND COULD HAVE IMPLICATIONS FOR REDUCING ANTIBIOTIC RESISTANCE AND COST SAVINGS AT THE SYSTEMS-LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2853219 MERSILENE TAPE UNKNOWN PRODUCT SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other