BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7627349 · Received June 21, 2018

    Report

    Report Number
    2210968-2018-73650
    Event Type
    Injury
    Date Received
    June 21, 2018
    Report Date
    May 29, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT 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 THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: HERNIA (2017) 21:795¿798; DOI 10.1007/S10029-017-1589-8. [(B)(4) - ABO-RYIA 2017 (1).PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: SIMPLE AND SAFE TECHNIQUE FOR CLOSURE OF MIDLINE ABDOMINAL WOUND DEHISCENCE AUTHOR: M. H. ABO-RYIA CITATION: HERNIA (2017) 21:795¿798; DOI 10.1007/S10029-017-1589-8; PUBLISHED ONLINE: 13 FEBRUARY 2017. THE AIM OF THIS STUDY WAS TO ASSESS AN ALTERNATIVE TECHNIQUE FOR CLOSURE OF BURST ABDOMEN. BETWEEN DECEMBER 2012 TO JUNE 2015, 11 PATIENTS (6 MALES AND 5 FEMALES) WITH BURST MIDLINE EXPLORATORY ABDOMINAL WOUND WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, THE OMENTUM IS FIXED TO THE PERITONEAL SIDE OF THE WOUND EDGE ALL-AROUND WITH INTERRUPTED PROLENE 3/0 SUTURES. A PIECE OF POLYPROPYLENE MESH WAS DESIGNED ACCORDING TO THE SIZE AND SHAPE OF THE DEFECT TO CLOSE IT WITHOUT TENSION AND SUTURED TO THE EDGES OF THE WOUND WITH CONTINUOUS 0 PROLENE SUTURE. ANOTHER LARGER POLYPROPYLENE MESH WAS PLACED TO COVER THE SMALLER ONE AND EXTEND OVER THE APONEUROSIS EXCEEDING THE DEFECT EDGES BY AT LEAST 5¿6 CM AND FIXED ALL-AROUND IN CIRCLES OF INTERRUPTED 2/0 PROLENE SUTURES TILL THE WOUND EDGES. AFTER IRRIGATION OF THE WOUND AREA WITH NORMAL SALINE SOLUTION SUCTION DRAINS WERE PLACED AND THE SKIN WAS CLOSED WITH INTERRUPTED 2/0 PROLENE STITCHES. WOUND INFECTION OCCURRED IN FIVE PATIENTS IN THE FORM OF LOCAL REDNESS AND TENDERNESS RESPONDED TO CONSERVATIVE TREATMENT IN THREE OF THEM WHILE ONE CASE NEEDED LOCAL DRAINAGE AND ONE WAS DUE TO STITCH SINUS CURED BY EXTRACTION OF THE OFFENDING STITCH. IN CONCLUSION, THIS TECHNIQUE PROVIDES A SIMPLE, SAFE AND EFFECTIVE ALTERNATIVE IN THE TREATMENT OF BURST ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468087 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention