BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GEL IMPLANTS

    MDR report key: 9868202 · Received March 23, 2020

    Report

    Report Number
    1645337-2020-04697
    Event Type
    Injury
    Date Received
    March 23, 2020
    Date of Event
    November 1, 2019
    Report Date
    February 28, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON JULY 1TH, 2020 ADDITIONAL INFORMATION RECEIVED, INDICATES THAT THE RIGHT IMPLANT WAS ALSO RUPTURED. AS A RESULT PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENTS AS FOLLOW: RIGHT REPLACED WITH CAT#:3507405MC, SN#: (B)(6) AND LEFT REPLACED WITH CAT#: 3507405MC, SN#: (B)(6) ON (B)(6) 2020. THIS REPORT IS FOR THE LEFT SIDE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    AFTER CLINICIAN SECOND REVIEW OF THIS FILE PERFORMED ON (B)(6) 2020, IT WAS DECIDED TO REMOVE PATIENT CODE: GENERALIZED ILLNESS TO MORE ACCURATELY CAPTURE THE REPORTED EVENT.¿ MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: NA. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH UNKNOWN SILICONE BREAST IMPLANTS WHICH LEFT RUPTURE / RIGHT PAIN. PATIENT TRIPPED AND FELL INTO FIRE DOOR IN NOVEMBER AND FELL DOWN THE STAIRS - PATIENT FELT LIKE CRASHING INTO A CEMENT WALL - CONCISION AND HEADACHES. SOMETIME IN DECEMBER GIANT CAT JUMPED DIRECTLY ONTO HER CHEST. WHEN PATIENT MOVES AND BREATHS IT HURTS. HAS GOTTEN BETTER, BUT THEN PAIN COMES BACK. SORE ACHY SHARP PAIN OVER TO THE RIGHT SIDE OF THE CHEST, ALL AROUND IMPLANT. CAN ALSO FEEL THERE'S SORENESS DIRECTLY BEHIND THE IMPLANT. MRI EXAMINATION EARLIER THIS MONTH CONFIRMED LEFT RUPTURE, AND INCONCLUSIVE FOR THE RIGHT SIDE. THESE ISSUES HAPPEN LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329172 UNKNOWN GEL IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R