BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 12315607 · Received August 12, 2021

    Report

    Report Number
    2210968-2021-07284
    Event Type
    Injury
    Date Received
    August 12, 2021
    Date of Event
    January 1, 2021
    Report Date
    August 3, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (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 CLARIFY 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 AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCT (MONOCRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE (OPERATIVE FAILURE OR RECURRENCES; SCROTAL IMPAIRMENT OF WOUND HEALING; INGUINAL HEMATOMA AND SCROTAL BLEEDING)? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (MONOCRYL SUTURE) USED IN THIS PROCEDURE/STUDY? PLEASE SPECIFY. IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (OPERATIVE FAILURE OR RECURRENCES; SCROTAL IMPAIRMENT OF WOUND HEALING; INGUINAL HEMATOMA AND SCROTAL BLEEDING) AND DETAILS OF EVENTS IF AVAILABLE. WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: JOURNAL OF PEDIATRIC UROLOGY (2021); 17, 82.E1-82.E5. HTTPS://DOI.ORG/10.1016/J.JPUROL.2020.10.020.

    Description of Event or Problem · 1

    TITLE: THE VALUE OF AN ADDITIONAL SCROTAL SUTURE DURING ORCHIDOPEXY. THE AIM OF THIS RETROSPECTIVE COHORT STUDY IS TO EVALUATE THE VALUE OF AN ADDITIONAL SCROTAL SUTURE BETWEEN THE TUNICA ALBUGINEA AND THE DARTOS FASCIA DURING ORCHIDOPEXY IN AN OUTPATIENT SETTING. BETWEEN JANUARY 2010 TO JANUARY 2018, A TOTAL OF 375 BOYS WITH PALPABLE UNDESCENDED TESTES OR WITH SONOGRAPHIC CONFIRMATION OF A NUBBIN WERE INCLUDED IN THE STUDY. IN GROUP 1 (2010-2014), 156 BOYS (MEDIAN AGE OF 39.6 (9.2-221.8) MONTHS) WITH A TOTAL OF 234 TESTES (78 BILATERAL, 32 LEFT, 46 RIGHT) UNDERWENT INGUINAL ORCHIDOPEXY-PROCEDURES (IOP) USING THE DARTOS POUCH TECHNIQUE FOR FIXATION OF THE TESTIS IN THE SCROTUM. SINCE 2014, IN GROUP 2, 219 BOYS (MEDIAN AGE OF 47.7 (9.7-203.3) MONTHS) WITH A TOTAL OF 327 TESTES (108 BILATERAL, 49 LEFT, 62 RIGHT) UNDERWENT IOP WITH AN ADDITIONAL FIXATION STITCH THROUGH THE TUNICA ALBUGINEA AND THE DARTOS FASCIA USING A 4-0 MONOCRYL (ETHICON). REPORTED COMPLICATIONS INCLUDED OPERATIVE FAILURE OR RECURRENCES (N=7); SCROTAL IMPAIRMENT OF WOUND HEALING (N=2); INGUINAL HEMATOMA (N=1); SCROTAL BLEEDING (N=1) WHICH REQUIRED THE PATIENT TO BE TRANSFERRED BACK IN THE OPERATION. IN CONCLUSION, ORCHIDOPEXY IS A SAFE PROCEDURE IN AN OUTPATIENT SETTING. SO FAR THERE IS NO EVIDENCE THAT PERFORMING AN ADDITIONAL SCROTAL SUTURE DECREASES THE OPERATIVE FAILURE RATE IN INGUINAL STANDARD ORCHIDOPEXY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213197 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention