BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD LITE

    MDR report key: 8844286 · Received July 30, 2019

    Report

    Report Number
    3005099803-2019-03800
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    June 11, 2019
    Report Date
    August 1, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTP
    UDI-DI
    08714729839200
    PMA / PMN Number
    K122459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK E1: DR. (B)(6) WAS THE PHYSICIAN WHO PERFORMED MESH REMOVAL. THE IMPLANTING PHYSICIAN'S DETAILS WERE NOT REPORTED. BLOCKS F10 AND H6: PATIENT CODES OF 1750 AND 3191 CAPTURE THE REPORTABLE EVENTS OF EROSION AND MESH REMOVAL. BLOCK G3: ANSM REFERENCE NO R1912920; SUBMITTED TO ANSM (AGENCE NATIONALE DE SECURITE DU MEDICAMENT) BY THE PHARMACIST. BLOCK H10: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. BLOCK H11: BLOCK D6 UPDATED TO PROVIDE THE CORRECT IMPLANT DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WITH CAPIO SLIM DEVICE WAS IMPLANTED DURING A PELVIC FLOOR REPAIR PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, THE PATIENT HAS EXPERIENCED PAIN, DISCOMFORT AND SENSATION OF RECURRENCE OF PROLAPSE. ON (B)(6) 2019, AFTER EXAMINATION, AN EXPLANTATION OF THE MESH WAS PERFORMED DUE TO SIGNS OF EROSION. REPORTEDLY, THE PATIENT STILL CURRENTLY EXPERIENCES PAIN AND DISCOMFORT, AND SENSATION OF RECURRENT PROLAPSE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: DR. (B)(6) WAS THE PHYSICIAN WHO PERFORMED MESH REMOVAL. THE IMPLANTING PHYSICIAN'S DETAILS WERE NOT REPORTED. (B)(4). REPORT SOURCE: (B)(6) REFERENCE NO (B)(4); SUBMITTED TO (B)(6) BY THE PHARMACIST. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WITH CAPIO SLIM DEVICE WAS IMPLANTED DURING A PELVIC FLOOR REPAIR PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, THE PATIENT HAS EXPERIENCED PAIN, DISCOMFORT AND SENSATION OF RECURRENCE OF PROLAPSE. ON (B)(6) 2019, AFTER EXAMINATION, AN EXPLANTATION OF THE MESH WAS PERFORMED DUE TO SIGNS OF EROSION. REPORTEDLY, THE PATIENT STILL CURRENTLY EXPERIENCES PAIN AND DISCOMFORT, AND SENSATION OF RECURRENT PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634647 UPHOLD LITE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN OTP BOSTON SCIENTIFIC CORPORATION M0068318170 ML00003332 08714729839200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention