BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19014743 · Received April 1, 2024

    Report

    Report Number
    2210968-2024-03727
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    June 26, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ITHIS 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. AN ATTEMPT HAS BEEN 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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED RELATED EVENTS CAPTURED VIA 2210968-2024-03726 AND 2210968-2024-03727 CITATION: CANCERS 2023, 15, 3345. HTTPS://DOI.ORG/10.3390/CANCERS15133345

    Description of Event or Problem · 0

    TITLE: FEASIBILITY OF PERINEAL DEFECT RECONSTRUCTION WITH SIMPLIFIED FASCIOCUTANEOUS INFERIOR GLUTEAL ARTERY PERFORATOR (IGAP) FLAPS AFTER TUMOR RESECTION OF THE LOWER RECTUM: INCIDENCE AND OUTCOME IN AN INTERDISCIPLINARY APPROACH THIS PAPER PRESENTS THE EXPERIENCE WITH THE UNI- OR BILATERAL INFERIOR GLUTEAL ARTERY PERFORATOR ADVANCEMENT FLAPS FOR RECONSTRUCTING PERINEAL DEFECTS AFTER THE RESECTION OF ANORECTAL MALIGNANCIES AND COMPARES THE OUTCOME REGARDING THE CLINICAL KEY PARAMETERS. FROM JANUARY 2017 TO SEPTEMBER 2021, 101 PATIENTS WITH LOW RECTAL CANCERS WHO UNDERWENT EXTRALEVATOR ABDOMINOPERINEAL EXCISION WERE INCLUDED IN THE STUDY. THERE WERE 72 MALES AND 29 FEMALES WITH A MEAN AGE OF 59.4 YEARS (RANGE, 25¿85) AND A MEAN BMI OF 25.7 KG/M2 (RANGE, 15.2¿41.8). THE PRIMARY DIRECT DEFECT CLOSURE WAS PERFORMED IN 72 PATIENTS. IN 29 PATIENTS, THE DEFECT WAS CLOSED WITH PRIMARY UNILATERAL OR BILATERAL INFERIOR GLUTEAL ARTERY PERFORATOR FLAPS IN VY FASHION. FOR THE PATIENTS WHO UNDERWENT FLAP RECONSTRUCTION AND THE PLASTIC DEFECT COVERAGE AFTER SURGERY, THE INSERTION OF THE DEEPITHELIALIZED FLAP BASE WAS PERFORMED WITH DELAYED ABSORBABLE SUTURE MATERIAL¿E.G., VICRYL 0 (ETHICON)¿FOR THE DEEP LAYER. THE DEEPITHELIALIZED FLAP WAS TRANSPOSED AS DEEPLY AS POSSIBLE INTO THE PELVIS AND SUTURE IT ONTO THE SACRUM, PRESACRAL LIGAMENTS, AND REMAINING PELVIC OUTLET. THE DONOR SITE WAS CLOSED IN V¿Y FASHION, AND THE REMAINING FLAP PORTIONS WERE SUTURED IN 3 LAYERS WITH ABSORBABLE SUTURES FOR SCARPA¿S FASCIA AND THE DEEP DERMAL LAYER. MEDIALLY, THE SKIN OF THE FLAP PLASTICS WAS SUTURED USING A DEEPLY PENETRATING, NON-ABSORBABLE MATERIAL¿E.G., PROLENE 0 (ETHICON)¿VIA THE DONATI TECHNIQUE (VERTICAL MATTRESS SUTURE) IN THE AREA WITH THE GREATEST TENSION. LATERALLY, THE SKIN WAS CLOSED USING NON-ETHICON INTRACUTANEOUS SUTURES OR SKIN STAPLES (MANUFACTURERS: UNKNOWN). PREVIOUSLY, REDON DRAINAGES WERE INSERTED FOR BOTH THE DEEP WOUND CAVITY AND THE SUPERFICIAL WOUND AREAS WITH BILATERAL DRAINAGE.THE NON-ABSORBABLE SUTURE MATERIAL WAS LEFT IN PLACE FOR 21 DAYS, AND THE REDON DRAINS FOR AT LEAST 7 DAYS, WITH AN EXPECTED PROLONGED DRAINAGE PHASE. AFTER SURGERY, SUPINE POSITIONING WAS ALLOWED FOR 5 DAYS, STARTING WITH SITTING TRAINING ON DAY 6. THE PATIENTS WERE MOBILIZED ON THE FIRST POSTOPERATIVE DAY. REPORTED COMPLICATIONS SURGICAL SITE INFECTION (N=4). IN CONCLUSION, USING INFERIOR GLUTEAL ARTERY PERFORATOR ADVANCEMENT FLAPS IS A RELIABLE, TECHNICAL EASY, AND SAFE OPTION, ESPECIALLY IN WIDER DEFECTS ON THE PELVIC FLOOR WITH MINIMAL DONOR SITE MORBIDITY AND AN ACCEPTABLE COMPLICATION (NO FLAP NECROSIS) RATE. THE DATA FOR HERNIA INCIDENCE IN THE LONG TERM ARE NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052252 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention