BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA, POLY-L-LACTIC ACID

    MDR report key: 3108496 · Received May 8, 2013

    Report

    Report Number
    3009443653-2013-00075
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 1, 2010
    Report Date
    May 12, 2010
    Manufacturer
    VALEANT USA
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: PB (B)(4) 2013. THE EVENT SEVERAL LUMPS ON THE PATIENT'S FACE ASSESSED AS SERIOUS, EXPECTED AND POSSIBLY RELATED. THE EVENT DEFORMITY ASSESSED AS SERIOUS, UNEXPECTED AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS IS A VERBATIM REPORT AS RECEIVED BY (B)(4) FROM SANOFI-AVENTIS; INITIAL REPORT: THIS NON-SERIOUS CASE FROM (B)(6) WAS RECEIVED FROM A PHYSICIAN ON (B)(6) 2010. UPON MEDICAL REVIEW, HAS BEEN UPGRADED TO SERIOUS BASED ON THE RECLASSIFICATION FOR THE EVENT(S) FOLLOWING ASSESSMENT UTILIZING THE COMPANY'S NEW DEVICE REPORTING TREE - LOCAL REFERENCE SW31622. THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHO RECEIVED 5 VIALS OF POLY-L-LACTIC ACID (SCULPTRA) THERAPY, WITH THE LAST TREATMENT GIVEN IN (B)(6) 2009. POLY-L-LACTIC ACID WAS INJECTED INTO THE CHIN, CHEEKS, AND NASOLABIAL AREAS. NO ADDITIONAL TREATMENT DETAILS WERE PROVIDED. THE PATIENT REPORTS THAT SHE IS QUITE CONCERNS AS SHE HAS HAD ONGOING PROBLEMS AFTER SHE RECEIVED TREATMENT WITH POLY-L-LACTIC ACID 2.5 TO 3 YEARS AGO. ONE MONTH AGO, THE PATIENT DEVELOPED LUMPS PRIMARILY IN THE CHIN AND CHEEKBONE AREAS. SOME OF THE LUMPS ARE SMALL AND NOT VISIBLE, BUT TWO ARE LARGE AND VISIBLE. THE LUMPS WERE MOSTLY ON THE JAWLINE, WITH 5 TO 6 LUMPS ON EACH CHEEK. THE PATIENT HAS UNDERGONE STEROID INJECTIONS, LASER, DERMABRASION NOS AND SURGERY TO HAVE THE LUMPS WERE CUT OUT OF MOUTH FROM INSIDE AND OUTSIDE, LASER TREATMENT, RECEIVED A COURSE OF STEROIDS, FOR WHICH SHE HAD 11 STITCHES. SHE HAS BEEN LEFT WITH A SCAR AND THE LUMPS HAVE NOT RESOLVED. THE PATIENT HAD A FACE LIFT TO TRY TO IMPROVE HER APPEARANCE. THIS MADE THE LUMPS WORSE AND EMPHASIZED THEM. THE PATIENT INQUIRED WHAT SHE COULD DO TO RESOLVE THE LUMPS. THE PATIENT WAS QUITE INSISTENT THAT IT WAS BECAUSE OF THE PRODUCT AND NOT TO DO WITH THE WAY IT WAS ADMINISTERED. SHE HAS BEEN TO HER DOCTOR WHO ADMINISTERED THE POLY-L-LACTIC ACID AND RECEIVED AS MUCH HELP AS HER DOCTOR COULD GIVE HER. SHE NOW DOES NOT KNOW WHAT ELSE TO DO. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WERE NOT MENTIONED. ACTION TAKEN: NOT APPLICABLE. OUTCOME: NOT RECOVERED/ NOT RESOLVED. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) WAS INITIATED: LOCAL PTC NUMBER GB20006; (B)(4). RESULTS FOR GLOBAL PTC # (B)(4) INDICATED THE FOLLOWING INFORMATION: SINCE NO LOT NUMBER IS AVAILABLE, AN INVESTIGATION HAS BEEN PERFORMED ON THE DOCUMENTATION OF ALL POTENTIALLY INVOLVED MANUFACTURED BATCHES MARKETED IN (B)(6). THE REVIEW OF THE DHRS (DEVICE HISTORY RECORD) AND OF THE ANALYTICAL RESULTS OF THESE BATCHES DIDN'T SHOW ANY ANOMALY THAT COULD BE RELATED TO THE EVENT OCCURRED. THE INVESTIGATION CONCLUSION: NO FAULTS DETECTABLE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010, IN THE FORM OF PTC INVESTIGATION RESULTS: RESULTS WERE RECEIVED FOR (B)(4). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011, FROM THE CONSUMER: ADDITIONAL DETAILS SURROUNDING THE EVENT WERE PROVIDED. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2011, FROM THE PATIENT: THE EVENT OF LUMPS ON JAWLINE WAS REMOVED AND "RUINED HER FACE" WAS ADDED. ADDITIONAL DETAILS SURROUNDING THE EVENT WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013, FROM THE PATIENT; TREATMENT WITH LASER TREATMENT, RECEIVED A COURSE OF STEROIDS WERE UPDATED. NARRATIVE UPDATED ACCORDINGLY. LAB TESTS UNKNOWN. NO FURTHER INFORMATION EXPECTED. FOR REFERENCE PURPOSES ONLY, THIS CASE HAS ALSO BEEN ASSIGNED THE FOLLOWING TRACKING NUMBER: (B)(4). THIS CASE WAS RECEIVED BY SANOFI-AVENTIS ON (B)(4) 2013 AND FORWARDED TO (B)(4) AS A SERIOUS CASE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200067 SCULPTRA, POLY-L-LACTIC ACID FACIAL IMPLANT LMH VALEANT USA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R