BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15114010 · Received July 27, 2022

    Report

    Report Number
    2210968-2022-05994
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    March 1, 2021
    Report Date
    August 4, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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? 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. CITATION: CHINESE REMEDIES & CLINICS, MARCH 2021, VOL. 21, NO. 6; DOI: 10.11655/ZGYWYLC2021.06.026.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 8/4/2022. 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. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? 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?

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC TRANSPERITONEAL PREPERITONEAL HERNIA REPAIR WITH OPEN PLUG - COMPARISON OF THERAPEUTIC EFFECTS OF REPAIR OF INGUINAL HERNIA IN ADULTS WITH PHOTOGRAPHIC TECHNIQUE. THIS PROSPECTIVE RANDOMIZED CONTROLLED STUDY AIMS TO COMPARE THE THERAPEUTIC EFFECTS OF 2 SURGICAL METHODS IN ADULT INGUINAL HERNIA. FROM JANUARY 2019 TO JANUARY 2020, 50 ADULT PATIENTS AGED 18 ~ 80 YEARS OLD, WITH INGUINAL HERNIA WHO RECEIVED SURGICAL TREATMENT WERE SELECTED AND DIVIDED INTO TEST GROUP WITH (24 MALES AND 1 FEMALE) AND CONTROL GROUP WITH (23 MALES AND 2 FEMALES). ACCORDING TO SURGICAL METHODS, WITH 25 CASES IN EACH GROUP. PATIENTS IN THE EXPERIMENTAL GROUP UNDERWENT TRANSPERITONEAL PREPERITONEAL HERNIORRHAPHY (TAPP) SURGERY, AND PATIENTS IN THE CONTROL GROUP UNDERWENT OPEN MESH-PLUG REPAIR. IN THE TEST GROUP, THE SPECIAL PATCH FOR 3D STEREOSCOPE (TIANZHU CHANGYUN MEDICAL TECHNOLOGY CO., LTD., (B)(4)) WAS USED FOR SURGERY; IN THE CONTROL GROUP, THE SPECIAL PATCH FOR 3D STEREOSCOPE WAS USED FOR SURGERY (TIANZHU CHANGYUN MEDICAL TECHNOLOGY CO., LTD., (B)(4)); (TIANZHU CHANGYUN MEDICAL TECHNOLOGY CO., LTD., (B)(4)); MEDICAL GLUE USED KANGPAITE MEDICAL GLUE (KANGPAITE MEDICAL INSTRUMENT CO., LTD., (B)(4)), AND SUTURE USED JOHNSON & JOHNSON VICRYL (JOHNSON & JOHNSON ETHICON, USA). DURING TRANSPERITONEAL PREPERITONEAL HERNIORRHAPHY (TAPP) SURGERY, THE PERITONEUM WAS SUTURED WITH ABSORBABLE SUTURES, NO BLEEDING OR INJURY WAS EXAMINED. IN THE CONTROL GROUP, THE ABSORBABLE SUTURE WAS USED TO SUTURE THE INCISION IN LAYERS AFTER EXAMINATION WITHOUT BLEEDING. PATIENTS WERE FOLLOWED UP FOR 5 MONTHS AFTER DISCHARGE. REPORTED COMPLICATIONS INCLUDED: TEST GROUP: (N=2) HEMATOMA. CONTROL GROUP: (N=7) HEMATOMA, (N=1) CASE OF RECURRENCE, AND (N=1) INFECTION. THE PATIENT WITH HEMATOMA WAS CURED AFTER SYMPTOMATIC DETUMESCENCE OBSERVATION AND TREATMENT, THE PATIENT WITH RECURRENCE WAS CURED AFTER OPEN INGUINAL HERNIA REPAIR AGAIN, AND THE PATIENT WITH INFECTION WAS CURED AFTER SYMPTOMATIC DRESSING CHANGE AND ANTI-INFECTION TREATMENT. IT WAS CONCLUDED, THAT COMPARED WITH OPEN PLUG-MESH REPAIR, TRANSPERITONEAL PREPERITONEAL HERNIORRHAPHY (TAPP) SURGERY NOT ONLY ENSURES THE SAFETY AND EFFICIENCY OF SURGERY, BUT ALSO SHORTENS THE HOSPITAL STAY AND REDUCES POSTOPERATIVE COMPLICATIONS. IT IS A GOOD TREATMENT METHOD FOR INGUINAL HERNIA AND HAS HIGH CLINICAL PROMOTION AND USE VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704017 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention