BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 7947647 · Received October 9, 2018

    Report

    Report Number
    1645337-2018-06067
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    May 9, 2018
    Report Date
    October 8, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2018, IT WAS REPORTED TO MENTOR THAT THE ADDITIONAL PTOSIS CODE WAS REPORTED INCORRECTLY. NO PTOSIS CODE WAS REQUIRED. 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 DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 750CC, CATALOG NUMBER 3502750, LOT NUMBER 6813524. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 750CC AND SALINE MENTOR BREAST IMPLANT OF UNKNOWN TYPE AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT. THE DEFLATION WAS DISCOVERED DURING THE SURGERY. THE RIGHT BREAST IMPLANT HAD A TINY PUNCTUATE WHERE THE SALINE WAS LEAKING. THE PATIENT ALSO EXPERIENCED BILATERAL BREAST PTOSIS AND BILATERAL BREAST IMPLANT MALPOSITION. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH SALINE NATRELLE ALLERGAN 750CC BREAST IMPLANTS ON (B)(6) 2018. THERE WERE NO COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT UNDERGONE FULL MASTOPEXY. THE PATIENT HAD UNDERGONE FOCAL LIPOSUCTION AND FAT GRAFTING TO THE ANTERIOR ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787614 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R