BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3941090 · Received July 7, 2014

    Report

    Report Number
    2135225-2014-00042
    Event Type
    Other
    Date Received
    July 7, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MERZ NORTH AMERICA
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING SYMPTOMS WERE REPORTED (ALL ARE RESOLVED): TAKO-TSUBO-SYNDROME, ONSET DATE: (B)(6) 2014 RESOLVED: 1 WEEK LATER. SEVERE SWELLING ON THE CHIN AND NLF (LEFT SIDE), ONSET DATE: (B)(6) 2014, RESOLVED: (B)(6) 2014. HEMATOMA ON THE CHIN AND NLF, ONSET DATE: (B)(6) 2014, RESOLVED: 1 WEEK LATER. MILD SWELLING ON THE CHIN AND NLF, ONSET DATE: (B)(6) 2014, RESOLVED: (B)(6) 2014. MEASURES TAKEN: CARDIAC CATHETERIZATION, MRI: REVEALED A HYPERTENSIVE HEART WITH SCREWPULL-LIKE VESSELS. TROPONIN T WAS ELEVATE IN THE BLOOD. A CAUSAL RELATIONSHIP TO THE RADIESSE DERMAL FILLER IS NOT SUSPECTED. THE RADIESSE LOT NUMBER WAS NOT PROVIDED, THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    A PT IN (B)(6) WAS INJECTED WITH RADIESSE IN THE NLF AND CHIN TO TREAT WRINKLES. THE PT SUFFERED FROM HEART PAIN 10 MIN AFTER INJECTION. THREE HOURS LATER, SHE WENT INTO HOSPITAL, WHERE A CARDIAC CATHETERIZATION AND MRI WERE PERFORMED. THE EXAMINATION REVEALED A TAKO-TSUBO-SYNDROME (ALSO: BROKEN-HEART-SYNDROME). THE PT WAS DISCHARGED AFTER ONE WEEK AND HAD COMPLETELY RECOVERED. THE PT HERSELF DID NOT SEE ANY RELATIONSHIP TO THE INJECTION. THE PT IS PHYSICIAN HERSELF BUT HAS BEEN INJECTED BY A COLLEAGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393834 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R BELOK ZOK MITE| RAMIPRIL