BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 12750223 · Received November 4, 2021

    Report

    Report Number
    2210968-2021-10884
    Event Type
    Injury
    Date Received
    November 4, 2021
    Date of Event
    March 12, 2021
    Report Date
    November 4, 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
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4). 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, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (PDS II SUTURE AND PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS (SUTURE KNOT REACTION (GRANULOMA/INFECTION OR ABSCESS) AND HERNIA RECURRENCE) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PDS II SUTURE AND PROLENE SUTURE) USED IN THIS STUDY? IF YES, PLEASE DESCRIBE. IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (SUTURE KNOT REACTION (GRANULOMA/INFECTION OR ABSCESS) AND HERNIA RECURRENCE)? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: JOURNAL OF PEDIATRIC SURGERY (2021); 56:1127¿1131. DOI: HTTPS://DOI.ORG/10.1016/J.JPEDSURG.2021.03.019. EVENTS WERE SUBMITTED VIA 2210968-2021-10883.

    Description of Event or Problem · 1

    TITLE: LONG-TERM ABSORBABLE VERSUS NON-ABSORBABLE SUTURE IN LAPAROSCOPIC PERCUTANEOUS EXTRAPERITONEAL CLOSURE OF INTERNAL RING FOR INGUINAL HERNIA IN CHILDREN THE AIM OF THIS RETROSPECTIVE COMPARATIVE STUDY OF A PROSPECTIVELY COLLECTED DATA WAS TO COMPARE THE RESULTS OF USING LONG-TERM ABSORBABLE (LTAS) VERSUS NON-ABSORBABLE SUTURE (NAS) IN LAPAROSCOPIC PERCUTANEOUS EXTRAPERITONEAL CLOSURE OF INTERNAL RING (LPEC) FOR INDIRECT INGUINAL HERNIA (IH) IN CHILDREN. A TOTAL OF 758 PATIENTS (597 BOYS AND 161 GIRLS; MEDIAN AGE OF 30 (1¿162) MONTHS; 734 UNILATERAL HERNIA AND 24 BILATERAL HERNIA) UNDERGOING LAPAROSCOPIC PERCUTANEOUS EXTRAPERITONEAL CLOSURE OF INTERNAL RING (LPEC) FOR INGUINAL HERNIA FROM JUNE 2016 TO DECEMBER 2017 WERE INCLUDED IN THE STUDY. IN THE FIRST PERIOD, 481 PATIENTS (GROUP A WITH 463 HAVING UNILATERAL HERNIA AND 18 HAVING BILATERAL HERNIA) WERE REPAIRED WITH NON-ABSORBABLE SUTURE (COMPETITOR DEVICE OR MONOFILAMENT POLYPROPYLENE - 2.0 PROLENE®, ETHICON, ACCORDING TO THE SURGEON¿S PREFERENCE). IN THE SECOND PERIOD OF TIME, 277 PATIENTS (GROUP B WITH 271 HAVING UNILATERAL HERNIA AND 6 HAVING BILATERAL HERNIA) WERE REPAIRED WITH LONG-TERM ABSORBABLE SUTURE (MONOFILAMENT POLYDIOXANONE - 2.0 PDS®, ETHICON). REPORTED COMPLICATIONS INCLUDE SUTURE KNOT REACTION (GRANULOMA/INFECTION OR ABSCESS) (N=1) REQUIRING ANTIBIOTIC TREATMENT, AND HERNIA RECURRENCE (N=21) REQUIRING REOPERATION USING SAME LAPAROSCOPIC TECHNIQUE BUT WITH DOUBLE LIGATION, OR REPAIRED BY OPEN SURGERY. IN CONCLUSION, THE USE OF PDS LONG-TERM ABSORBABLE SUTURE IN LAPAROSCOPIC PERCUTANEOUS EXTRAPERITONEAL CLOSURE OF INTERNAL RING FOR PEDIATRIC INGUINAL HERNIA IS ASSOCIATED WITH NO SUTURE KNOT REACTION BUT HIGHER HERNIA RECURRENCE RATE COMPARED TO THE NON-ABSORBABLE SUTURES. WE RECOMMEND MONOFILAMENT NON-ABSORBABLE SUCH AS PROLENE IN LPEC FOR INGUINAL HERNIA IN CHILDREN BECAUSE OF ITS LOW RATE OF BOTH RECURRENCE AND SUTURE KNOT REACTION. THE PATIENTS WILL BENEFIT FROM FUTURE TECHNICAL MODIFICATIONS TO FURTHER REDUCE THE INCIDENCE OF HERNIA RECURRENCE AND SUTURE KNOT REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649730 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention