BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 19615065 · Received June 26, 2024

    Report

    Report Number
    2210968-2024-06632
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    October 18, 2023
    Report Date
    June 26, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: EUROPEAN JOURNAL OF PLASTIC SURGERY (2023) 46:1219¿1225. HTTPS://DOI.ORG/10.1007/S00238-023-02127-4.

    Description of Event or Problem · 0

    TITLE: THE USE OF GLUTEUS MAXIMUS TO RESTORE THE FUNCTION OF THE PELVIC DIAPHRAGM IN THE RECONSTRUCTION OF THE PELVIC OUTLET AFTER ABDOMINO-PERINEAL RESECTION: A CASE SERIES. THIS ARTICLE DESCRIBES AN ALTERNATIVE METHOD FOR PELVIC OUTLET RECONSTRUCTION BASED ON A SINGLE, PEDICLED, GLUTEUS MAXIMUS MUSCLE. A CASE SERIES PRESENTING 4 PATIENTS UNDERGOING RECONSTRUCTION FOLLOWING ABDOMINO-PERINEAL RESECTION (AP RESECTION), BETWEEN 2013 AND 2018, WAS PERFORMED, IN A TERTIARY CENTRE WITH AN ESTABLISHED SERVICE PROVIDING ABDOMINAL AND PERINEAL RECONSTRUCTION. THE AVERAGE LENGTH OF FOLLOW UP WAS 3 YEARS. IN TWO CASES, THE GLUTEAL MUSCLE FAP RECONSTRUCTION WAS PERFORMED AT THE TIME OF THE PRIMARY SURGERY. IN THE REMAINING CASES, THE GLUTEAL MUSCLE FLAP WAS USED TO RECONSTRUCT PELVIC OUTLET DEFECTS IN PATIENTS WHO HAD DEVELOPED SYMPTOMATIC HERNIATION OF THEIR INTRA-ABDOMINAL CONTENTS IN THE POST-OPERATIVE PERIOD FOLLOWING THE ORIGINAL AP RESECTION. THE TECHNIQUE IS IDENTICAL WHETHER PERFORMED PRIMARILY OR AS A DELAYED PROCEDURE. SURGERY WAS PERFORMED USING 2/0 OR 3/0 PDS SUTURE ON A ROUND-BODIED NEEDLE, A PIECE OF ALLOPLASTIC MATERIAL (PERMACOL AND PROLENE MESH), AND 3/0 MONOCRYL SUTURE. REPORTED COMPLICATIONS INCLUDE: A 76-YEAR-OLD WOMAN (N=1) - NATAL CLEFT WOUND DEHISCENCE AND DISCOMFORT AND NUMBNESS WHEN SITTING TREATMENT: RE-EXPLORATION OF THE WOUND WAS PERFORMED 1 WEEK POST-OPERATIVELY, CONFIRMING AN INTACT GLUTEUS MUSCLE FAP WITH NO EXPOSED MESH. THE WOUND SUBSEQUENTLY HEALED, AND THE DISCOMFORT AND OTHER SYMPTOMS RELATED TO HER HERNIA RESOLVED COMPLETELY. SHE REMAINED SYMPTOM-FREE AT 5 YEARS POST-OPERATIVELY. - (N=3) DEHISCENCE OF THE PERINEAL WOUND WITHIN 4 WEEKS POST-OPERATIVELY; DISCOMFORT AND NUMBNESS WHEN SITTING ON THEIR RIGHT BUTTOCK (OR LEFT BUTTOCK IN ONE CASE) FOR UP TO 6 MONTHS AFTER SURGERY. TREATMENT: NO PATIENTS REQUIRED SURGICAL MANAGEMENT FOR INFECTION OR EXPOSED MESH. THE DISCOMFORT AND NUMBNESS SUBSEQUENTLY RESOLVED. IN CONCLUSION, THE PEDICLED GLUTEUS MUSCLE FAP PROVIDES AN OPTION FOR LOCAL RECONSTRUCTION OF LARGE PERINEAL DEFECTS, AS IT CREATES AN INNERVATED MUSCLE SLING TO RESTORE THE SUPPORT FUNCTION OF THE PELVIC DIAPHRAGM, REDUCING THE RISK OF LONG-TERM HERNIA FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625765 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other