BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTROLLER VEST 104

    MDR report key: 3982587 · Received June 24, 2014

    Report

    Report Number
    3008145987-2014-00007
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 10, 2013
    Report Date
    January 13, 2014
    Manufacturer
    HILLROM SERVICES PRIVATE LIMITED
    Product Code
    BYI
    PMA / PMN Number
    K024309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A HILL-ROM REPRESENTATIVE SPOKE WITH THE PATIENT TO ASK ABOUT ADDITIONAL INFORMATION REGARDING HER BREAST IMPLANT LEAKING. THE PATIENT COULD NOT CONFIRM THAT THE VEST CAUSED THE LEAK IN HER BREAST IMPLANT. IT WAS A SLOW LEAK THAT LET TO HER HAVING SURGERY TO REPAIR IN (B)(6) 2013. NO OTHER SURGERY OR MEDICAL TREATMENT WAS SOUGHT. THE PATIENT STATED USING THE VEST FOR A PREEXISTING CONDITION OF BRONCHIECTASIS. SHE STOPPED USING THE VEST IN (B)(6) OF 2013. THE PATIENT DID NOT ALLEGE ANY MALFUNCTION WITH THE VEST. THE RISK OF SALINE BREAST IMPLANT DEFLATION IS ABOUT 1% PER IMPLANT PER YEAR. SILICONE GEL BREAST IMPLANT RUPTURE RATE IS ABOUT (B)(4) DURING THE FIRST FOUR YEARS, WHICH MAKE THE ROUGHLY EQUIVALENT DURING THAT TIME FRAME. BREAST IMPLANTS ARE ENGINEERED TO WITHSTAND A LARGE AMOUNT OF SUDDEN PRESSURE AND AN EVEN LARGER AMOUNT OF GRADUALLY INCREASING PRESSURE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE VEST HAD BROKEN HER BREAST IMPLANTS. SHE WAS NOT SURE THAT IT DID BECAUSE THEY DID NOT GO FLAT IMMEDIATELY. THE CONSUMER STATED SHE USED THE VEST FOR A VERY SHORT PERIOD OF TIME, APPROXIMATELY SIX WEEKS BEFORE SHE NOTICED THE BREAST IMPLANT ISSUE. THE CONSUMER STATED SHE HAD SURGERY TO REPAIR HER BREAST IMPLANTS ON (B)(6) OF 2013. THE PATIENT'S PULMONOLOGIST SUGGESTED THAT SHE CONTACTED HILL-ROM TO SEE IF A VEST WAS AVAILABLE THAT WOULD FIT UNDER HER BREAST. THE PATIENT FEELS THE VEST DID NOT HELP HER LUNG ISSUE AND THAT IT DID NOT LOOSEN THE MUCUS THAT HER CONDITION PRODUCES. THE VEST WAS USED IN THE PATIENT'S HOME. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368829 CONTROLLER VEST 104 VEST BYI HILLROM SERVICES PRIVATE LIMITED P105CM

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization