BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 23051406 · Received September 15, 2025

    Report

    Report Number
    2210968-2025-10473
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    July 7, 2025
    Report Date
    September 15, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SO
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: INT MED CASE REP J. 2025 JUL 7; 18:845-850. HTTPS://DOI.ORG/10.2147/IMCRJ.S478373 PMID: 40656889; PMCID: PMC12248728.

    Description of Event or Problem · 0

    TITLE: CHALLENGES IN DIAGNOSIS AND MANAGEMENT OF ACUTE LIMB ISCHEMIA 30 DAYS POSTPARTUM IN LITHOTOMY POSITION: A CASE REPORT FROM SOMALIA LEADING TO BILATERAL LOWER LIMB AMPUTATION. THIS CASE PRESENTS A RARE AND SEVERE INSTANCE OF ACUTE LIMB ISCHEMIA (ALI) IN POSTPARTUM PATIENTS WHOSE INITIAL SYMPTOMS MIMICKED NEUROLOGICAL DISORDERS, ULTIMATELY LEADING TO LIMB AMPUTATION DESPITE IMMEDIATE MEDICAL INTERVENTION. A 31-YEAR-OLD POSTPARTUM WOMAN, 30 DAYS AFTER DELIVERY, PRESENTED TO THE EMERGENCY DEPARTMENT WITH BILATERAL LOWER LIMB PARALYSIS AND PARESTHESIA. THE PATIENT UNDERWENT BILATERAL POPLITEAL ARTERY THROMBOEMBOLECTOMY. UNDER GENERAL ANESTHESIA, A POSTERIOR APPROACH WAS USED TO EXPOSE AND CLAMP THE POPLITEAL ARTERIES. ARTERIOTOMIES WERE PERFORMED, AND THROMBI WERE EXTRACTED PROXIMALLY AND DISTALLY. ADEQUATE INFLOW WAS CONFIRMED BILATERALLY, AND THE ARTERIOTOMIES WERE CLOSED WITH 7¿0 PROLENE SUTURES. HEMOSTASIS WAS ACHIEVED, DRAINS WERE PLACED, AND THE WOUNDS WERE CLOSED IN LAYERS. POSTOPERATIVELY, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND STARTED ON SYSTEMIC HEPARIN THERAPY. REPORTED COMPLICATIONS ARE PROLENE SUTURES. 31-YEAR-OLD FEMALE PATIENT. SURGICAL BLOOD LOSS. TREATMENT: NECESSITATING TRANSFUSION WITH TWO UNITS OF ERYTHROCYTES. PROGRESSIVE BILATERAL LEG EDEMA. TREATMENT: FASCIOTOMY. INCREASED PAIN. TREATMENT: FASCIOTOMY. IN CONCLUSION, THIS CASE OF BILATERAL ACUTE LIMB ISCHEMIA LEADING TO AMPUTATION IN A POSTPARTUM PATIENT HIGHLIGHTS THE DEVASTATING POTENTIAL OF THIS RARE VASCULAR EMERGENCY. THE PRIMARY CLINICAL TAKEAWAY IS THE NECESSITY FOR CLINICIANS TO MAINTAIN A HIGH INDEX OF SUSPICION FOR ALI IN POSTPARTUM PATIENTS PRESENTING WITH LOWER LIMB SYMPTOMS, EVEN WHEN THEY RESEMBLE NEUROLOGICAL DISORDERS. A PROMPT, COMPREHENSIVE DIAGNOSTIC EVALUATION, INCLUDING EARLY VASCULAR IMAGING AND MULTIDISCIPLINARY CONSULTATION, IS PARAMOUNT TO PREVENT CATASTROPHIC OUTCOMES. FUTURE RESEARCH SHOULD FOCUS ON IDENTIFYING SPECIFIC RISK FACTORS FOR POSTPARTUM ARTERIAL THROMBOSIS AND IMPROVING RISK-STRATIFICATION PROTOCOLS TO ENHANCE EARLY DETECTION AND PATIENT PROGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519187 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention