BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 10632413 · Received October 5, 2020

    Report

    Report Number
    1645337-2020-12532
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    January 1, 2003
    Report Date
    September 16, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020, AND (B)(6) 2020, MENTOR BECAME AWARE THAT PATIENT EXPERIENCED BILATERAL TOXIC REACTION, LEFT SIDE DEFLATION, LEFT SIDE CHEST INJURY, RIGHT SIDE WOUND INFECTION, AND RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN, IN ADDITION TO GENERALIZED ILLNESS SYMPTOMS INCLUDING BRAIN FOG, FATIGUE, NIGHT SWEATS, RASHES AND LEGIONS SKIN, RENAL FAILURE, HIGH BLOOD PRESSURE, POSSIBLY DIABETIC, TEETH FELL OUT, SHORT TERM MEMORY LOSS, LOSS OF MUSCLE, HEAD FEELS LIKE ITS ON FIRE, TROUBLE WITH STOMACH, BONES FOUND BLACK MOLD, NODULES ALL OVER THYROID, CONNECTIVE TISSUE DISEASE, HEART HEMORRHAGE, TUMOR ON RIGHT TEMPORAL AREA, LARGE INFECTION, HEAD BURNING AND LESIONS THAT FORM ON MY SCALP. THE FOLLOWING UPDATES HAVE BEEN MADE ON THIS FORM: - ADDED DATE OF EVENT "1/1/2003" TO FIELD B3 - ADDED PATIENT DATE OF BIRTH "10/14/1966" TO FIELD A2 - BELOW INFORMATION IS FOR THE LEFT SIDED - FIELD D1 FOR BRAND NAME HAS BEEN UPDATED TO "MENTOR SILTEX ROUND MODERATE PROFILE" - FIELD D2A FOR COMMON DEVICE NAME HAS BEEN UPDATED TO "PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE" - FIELD 2B FOR PROCODE HAS BEEN UPDATED TO "FWM" - FIELD D4 FOR CATALOG NUMBER HAS BEEN UPDATED TO "3542650" - FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "188825" - FIELD D4 FOR UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO "00081317001799" - FIELD G4 FOR PMA/ 510(K) HAS BEEN UPDATED TO "P990075" - UPDATE DATE OF IMPLANT FROM "1/1/2005" TO "12/07/1999" UNDER FIELDS D6A - UPDATED DATE OF EXPLANT FROM "1/1/2017" TO "12/29/2017" UNDER FIELD D6B - UPDATED FIELD H6 FOR TYPE OF INVESTIGATION "DEVICE DISCARDED" ON THIS FORM - APPROPRIATE TERM/ CODE NOT AVAILABLE, AND CHEST INJURY CODES HAVE BEEN ADDED TO HEALTH EFFECT - CLINICAL CODE FIELD H6. THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. H6 HEALTH EFFECT - CLINICAL CODE E2402: GENERALIZED ILLNESS, AND TOXIC REACTION (NOS) ON (B)(6) 2020, MENTOR BECAME AWARE THAT FIELD B2 "IS LIFE THREATENING" WAS MISTAKENLY SELECTED UNDER THE PREVIOUS SUBMISSION INSTEAD OF "IS REQUIRED INTERVENTION". THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). B2

    Additional Manufacturer Narrative · 0

    AFTER SECONDARY REVIEW OF THIS FILE PERFORMED ON JANUARY 4, 2022, THE PATIENT'S DATE OF BIRTH HAS BEEN CORRECTED TO (B)(6) 1956 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: UNKNOWN SIDE RUPTURE, AND LOCAL REACTION. (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT OF AN UNKNOWN AGE, RACE, AND ETHNICITY UNDERWENT UNSPECIFIED BREAST SURGERY WITH UNKNOWN SIZE UNKNOWN GEL IMPLANTS ON BOTH SIDES AND EXPERIENCED UNKNOWN SIDE BREAST IMPLANT RUPTURE AND BILATERAL LOCAL REACTION. AS A RESULT, THE DEVICES WERE EXPLANTED SOME TIME IN 2017-2018. THIS REPORT IS FOR THE SIDE WITH LOCAL REACTION IN ADDITION TO BREAST IMPLANT RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096537 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 188825
    1096539 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 188825

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Life Threatening| R