BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA, POLY-L-LACTIC ACID

    MDR report key: 3902307 · Received June 25, 2014

    Report

    Report Number
    3009443653-2014-00217
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    May 26, 2014
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HEART DISEASE CONGENITAL, MATERNAL DRUGS AFFECTING FOETUS ASSESSED A SERIOUS AND UNASSESSABLE.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(4) 2014 FROM A CONSUMER AND CONCERNS A FETUS. THE PT'S MED HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNK DATE IN (B)(6) 2014, A FEMALE CONSUMER (AGE GROUP: ADULT) WAS APPLICATED WITH SCULPTRA. AFTER APPLICATION, SHE LEARNED THAT SHE WAS FOUR WEEKS INTO PREGNANCY. SHE HAD BEEN PRESCRIBED ANTIBIOTICS AND ANTI-INFLAMMATION AGENTS AFTER APPLICATION OF SCULPTRA. ON AN UNK DATE THE GYNECOLOGIST SUSPECTED FETAL HEART MALFORMATION. THE PT WAS (B)(6) AT THE TIME OF REPORT. THE PT'S DOCTOR EXPLAINED SCULPTRA DISINTEGRATED IN THE BODY AND CONSIDERED THERE WAS NO RISK AT PREGNANCY CAUSED BY SCULPTRA. THE PT DID NOT CONSENT ON LOCAL PRIVACY LAW SO NO FURTHER INFO IS AVAILABLE. FOR REFERENCE PURPOSES ONLY, THIS CASE HAS ALSO BEEN ASSIGNED THE FOLLOWING TRACKING NUMBERS: (B)(4) INOVA). FOLLOW UP REQUEST NOT SENT AS PT DID NOT PROVIDE CONSENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370297 SCULPTRA, POLY-L-LACTIC ACID INJECTABLE DERMAL FILLER LMH

    Patients

    Seq Age Sex Outcome Treatment
    1 FETUS Congenital Anomaly