BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 20667526 · Received November 12, 2024

    Report

    Report Number
    2210968-2024-11890
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    June 19, 2023
    Report Date
    November 12, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NI
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J CLIN PRACT 2023; 26:630-5; HTTPS://DOI.ORG/10.4103/NJCP.NJCP_830_22.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF PREGNANCY OUTCOMES OF TRIANGULAR 3-BITES AND MCDONALD TECHNIQUES OF CERVICAL CERCLAGE IN WOMEN WITH CERVICAL INSUFFICIENCY: A PILOT STUDY. THIS IS TO COMPARE THE EASE/DURATION OF APPLICATION AND PREGNANCY OUTCOMES OF THE NEW TRIANGULAR THREE-BITE CERVICAL CERCLAGE TECHNIQUE AND MCDONALD¿S TECHNIQUE IN WOMEN WITH CERVICAL INSUFFICIENCY. 20 PREGNANT WOMEN BETWEEN THE AGES OF 18 AND 45 YEARS WITH HISTORY-INDICATED AND ULTRASOUND-INDICATED CERVICAL CERCLAGE WERE INCLUDED IN THE STUDY. THEY WERE RANDOMLY GROUPED INTO TRIANGULAR 3-BITE METHOD (N = 10) AND MCDONALD¿S METHOD (N = 10). CERVICAL CERCLAGE WAS INSERTED FOR BOTH GROUPS BETWEEN 14 AND 16 WEEKS OF GESTATIONAL AGE. 5 MM MERSILENE TAPE (ETHICON) WAS USED FOR SUTURE PLACEMENT IN BOTH GROUPS. PARTICIPANTS IN BOTH GROUPS WERE ADMITTED TO THE RECOVERY ROOM FOR OBSERVATION AND MONITORING IMMEDIATELY AFTER THE PROCEDURE. THESE PATIENTS WERE DISCHARGED WITHIN 6 HOURS IF THEY REMAIN STABLE. REPORTED COMPLICATIONS INCLUDED SPONTANEOUS MISCARRIAGE (N=2), PRETERM DELIVERY (N=5), AND ABDOMINAL CRAMPS (N=3). IN CONCLUSION, THE DURATION OF APPLICATION WAS SHORTER; EASE OF APPLICATION WAS BETTER AND ESTIMATED BLOOD LOSS WAS LESS IN THE TRIANGULAR THREE-BITE TECHNIQUE COMPARED TO THE MCDONALD¿S TECHNIQUE. HOWEVER, BOTH TECHNIQUES HAVE SIMILAR PREGNANCY OUTCOMES. A WELL-STRUCTURED RANDOMIZED CONTROLLED TRIAL IS FURTHER RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058782 MERSILENE TAPE UNKNOWN PRODUCT SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other