BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 12489242 · Received September 17, 2021

    Report

    Report Number
    2210968-2021-08597
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    February 19, 2020
    Report Date
    August 23, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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? WAS ANY MEDICAL OR SURGICAL INTERVENTION PROVIDED FOR THE REPORTED HERNIA RECURRENCE OR PROMINENT RETAINED SUTURE? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2021-08598. CITATION: SURGICAL ENDOSCOPY (2021); 35:854¿859. HTTPS://DOI.ORG/10.1007/S00464-020-07457-Z.

    Description of Event or Problem · 1

    TITLE: MODIFIED PERCUTANEOUS INTERNAL RING SUTURING WITH PERITONEAL INJURY IN CHILDREN: MATCHED COMPARISON TO OPEN HERNIA REPAIR. THE PRIMARY AIM OF THIS RETROSPECTIVE STUDY WAS TO ELUCIDATE THE OUTCOMES OF PERCUTANEOUS INTERNAL RING SUTURING (PIRS) WITH PARTIAL FULGURATION OF THE HERNIA SAC IN A LARGE NUMBER OF PEDIATRIC PATIENTS AND TO COMPARE THE OUTCOMES WITH OPEN INGUINAL HERNIA REPAIRS (OHR). THE SECONDARY AIM OF THE STUDY WAS TO ELUCIDATE THE ROLE OF THIS TECHNIQUE IN EVALUATING THE CONTRALATERAL INTERNAL INGUINAL RING DURING LAPAROSCOPY. THERE WERE 213 PATIENTS (23% WERE FEMALES; MEDIAN AGE OF 420 DAYS) WHO UNDERWENT OPEN INGUINAL HERNIA REPAIRS (OHR) AND 90 PATIENTS (23% WERE FEMALES; MEDIAN AGE OF 149 DAYS) UNDERWENT PERCUTANEOUS INTERNAL RING SUTURE (PIRS TECHNIQUE BETWEEN JANUARY 2017 TO SEPTEMBER 2018. THESE PATIENTS WERE THEN MATCHED BASED ON AGE, SEX, FOLLOW-UP TIME, SIDE OF HERNIA, REPAIR OF CONTRALATERAL HERNIA, AND NUMBER OF ADDITIONAL PROCEDURES. A TOTAL OF 90 MODIFIED PIRS PATIENTS WERE MATCHED TO 90 OHRS. THE PIRS TECHNIQUE WAS PERFORMED USING 3-0 PROLENE SUTURE (ETHICON) AND ETHIBOND SUTURE (ETHICON). REPORTED COMPLICATIONS INCLUDED RECURRENCE (N=3) AND PROMINENT RETAINED SUTURE (N=1). IN CONCLUSION, PIRS WITH PERITONEAL INJURY HAS COMPARABLE EFFICACY AND GOOD SAFETY COMPARED TO OHR. RECURRENCE AND COMPLICATION RATES SHOULD FURTHER IMPROVE WITH INCREASING EXPERIENCE. FUTURE STUDIES SHOULD ELUCIDATE LONG TERM OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387144 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1