BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18818568 · Received March 1, 2024

    Report

    Report Number
    2210968-2024-02210
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    February 1, 2022
    Report Date
    March 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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. 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. CITATION: SAGE OPEN MEDICAL CASE REPORTS, (2022); 10 (XX): 1-4. HTTPS://DOI.ORG/10.1177/2050313X221081371.

    Description of Event or Problem · 0

    TITLE: RARE CASE OF OBTURATOR HERNIA: SURGICAL ANATOMY, PLANNING, AND CONSIDERATIONS. A CASE REPORT OF A 89-YEAR-OLD FEMALE PRESENTED WITH COMPLAINTS OF ABDOMINAL PAIN, NAUSEA, AND VOMITING FOR APPROXIMATELY 6 DAYS. PATIENT COMPLAINED OF PAIN IN HER LEFT INGUINAL REGION AND INCREASING ABDOMINAL DISTENSION. PATIENT¿S LAST BOWEL MOVEMENT WAS 2 DAYS PRIOR TO PRESENTATION. ON EXAMINATION, THE PATIENT WAS HEMODYNAMICALLY STABLE, HOWEVER THIN AND FRAIL WITH A BODY MASS INDEX (BMI) OF 18. HER LEFT LEG WAS FLEXED AND SHE WAS APPEARED VERY UNCOMFORTABLE. THE ABDOMEN WAS DISTENDED WITH VOLUNTARY GUARDING IN THE LOWER QUADRANTS. BOWEL SOUNDS WERE HYPOACTIVE. THERE WAS NO PALPABLE MASS IN THE INGUINAL REGION OR INGUINAL CANAL. THE PATIENT REPORTEDLY UNDERWENT LADD PROCEDURE APPROXIMATELY MONTHS PRIOR DUE TO MALROTATION, RESULTING IN A 20-POUND WEIGHT LOSS. PATIENT DENIES HISTORY OF CHRONIC CONSTIPATION OR BOWEL ISSUES PRIOR TO THIS PAST YEAR. A COMPUTED TOMOGRAPHY (CT) OF HER ABDOMEN AND PELVIS WITH CONTRAST WAS OBTAINED WHICH REVEALED DILATED LOOPS OF SMALL BOWEL AND EVIDENCE OF A LOOP OF BOWEL THROUGH THE LEFT OBTURATOR FORAMEN, SIGNIFICANT FOR AN OBTURATOR HERNIA. INFORMED CONSENT WAS OBTAINED AND SHE WAS TAKEN TO THE OPERATING ROOM FOR SURGICAL EXPLORATION. THIS PATIENT WAS TREATED WITH 2-0 PROLENE, 3-0 VICRYL SUTURES AND NON-ETHICON MESH. THE FOLLOWING EVENTS CANNOT BE RULED OUT AS COMPLAINTS: PATIENT INFORMATION: 2-0 PROLENE SUTURE >89 YEAR OLD, FEMALE. FASCIAL DEHISCENCE POSTOPERATIVE DAY 3 REQUIRING ADDITIONAL PROCEDURE. SLOW RETURN OF BOWEL FUNCTION. TREATMENT: NOT MENTIONED. IN CONCLUSION, LITERATURE ON LAPAROSCOPIC VERSUS LAPAROTOMY, AS WELL AS TYPES OF CLOSURE (PRIMARY VS MESH) HAVE NOT BEEN WELL DESCRIBED IN THE LITERATURE. THIS IS PARTLY DUE TO THE RARITY OF THESE HERNIAS AND NEW TECHNIQUES OF LAPAROSCOPIC SURGERY. OBTURATOR HERNIAS, ALTHOUGH RARE, REQUIRE A HIGH INDEX OF SUSPICION AND CARE IN SURGICAL MANAGEMENT AS MANY OF THESE PATIENTS WILL BE ELDERLY WITH A MULTITUDE OF COMORBID CONDITIONS. FURTHER RESEARCH AND REPORTING ON TECHNIQUE AND TYPE OF CLOSURES UTILIZED WHEN THESE RARE HERNIAS ARE ENCOUNTERED BY SURGEONS WOULD BENEFIT THE SURGICAL COMMUNITY ON PRACTICES AND MANAGEMENT OF OBTURATOR HERNIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2002274 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Required Intervention