BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 10190923 · Received June 24, 2020

    Report

    Report Number
    1645337-2020-07735
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    October 1, 2017
    Report Date
    June 4, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON JUNE 29, 2020, MENTOR BECAME AWARE THAT INCORRECT MANUFACTURER SITE PHONE NUMBER WAS INADVERTENTLY REPORTED UNDER PREVIOUS INITIAL SUBMISSION. IT HAS BEEN CORRECTED UNDER SECTION G ON THIS FORM. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEVICE EXTRUSION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE US THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY RECONSTRUCTION BREAST SURGERY WITH MENTOR MEDICAL DEVICES (UNK_SALINE IMPLANTS, DATE OF IMPLANT (B)(6) 2017) EXPERIENCED LEFT BREAST IMPLANT EXTRUSION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION, AND REPLACEMENT WITH CATALOG NUMBER 3502325; LOT NUMBER 6800322 ON (B)(6) 2017. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS CASE. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS CONSIDERED SERIOUS AND REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656415 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention