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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SCULPTRA, POLY-L-LACTIC ACID; INJECTABLE DERMAL FILLER

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SCULPTRA, POLY-L-LACTIC ACID; INJECTABLE DERMAL FILLER Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Emotional Changes (1831); Erythema (1840); Granuloma (1876); Headache (1880); Inflammation (1932); Swelling (2091); Reaction (2414); Numbness (2415); Sleep Dysfunction (2517)
Event Date 08/10/2012
Event Type  Injury  
Event Description
This spontaneous case, via medical records, was received on (b)(6) 2013 and concerns a (b)(6) year old female patient.The patient's medical history included severe allergy to flagyl, hypertension, hyperlipidemia, asthma, (b)(6), peptic disease, kidney disease, right mastoid operation, depression, mini-facelift, fatigue, mild breathlessness, internal hemorrhoids.The patient had negative history for tobacco and alcohol use.Sometime in (b)(6) of 2011, the pt started treatment with sculptra (injectable poly-l-lactic acid) injections for an unk indication.The pt underwent a total of 3 injections in the time frame.The batch number used was not reported.Expiration date was not reported.The pt also saw multiple physicians during this time.On (b)(6) 2012, the pt underwent an aggressive microdermabrasion.On (b)(6) 2012, the pt underwent botox injections to the forehead/glabellar and crow's feet regions.On (b)(6) 2012, the pt experienced swelling of the face and intermittent numbness.The physician assessed that the pt had subcutaneous collagen nodules.The physician reported that this is a known side effect of sculptra.The pt was treated with intralesional kenalog 3mg/ml and intralesional normal saline.It was reported this treatment has softened the nodules considerably over time.The pt saw her internist and was prescribed augmentin 875mg bid for 10 days to treat the adverse event, which provided some improvement.Later on the pt saw an ent specialist and was placed on treatment of prednisone 40mg for four days with a taper over 12 days.The pt did not see much improvement.The pt was eventually started on a second course of prednisone therapy.It was mentioned to the pt that the nodules will probably persist over the following year or two.On (b)(6) 2013, the pt was diagnosed with a scar on the left cheek.It was reported by the physician that the event is compatible with a reaction to injected poly-l-lactic acid.It was reported that the pt also experienced granulomas palpable in cheeks, lumps on the face (bilateral cheek, infra-orbital areas), insomnia, masses under the skin, redness inflammation, headaches, solidified foreign body production and material (not limited to but especially around cheek, including, but not limited to granulomas) and quality of life loss.The onset date of events was not reported.Follow-up info received in the form of medical record on (b)(6) 2013, the pt had collagen nodule.After that the pt had follow-up visit with physician for collagen nodule on: (b)(6) 2012, (b)(6) 2013.Most recently pt visited physician on (b)(6) 2013 for collagen nodule.The pt received sculptra injection 2011 (sometime in (b)(6)).Follow-up info received in the form of medical records on (b)(6) 2013.Following consultation on (b)(6) 2012.On physical examination, the pt was febrile (98.6 ear).Her cheeks were bilaterally swollen.She had hard liner nodules over her zygomas.She had scatter nodularity on her cheeks, extending to preauricular areas to the modiolus bilaterally.Her cheeks were swollen beyond the nodularity.Nodules are not tender.She had no adenopathy in the preauricular, postauricular, or cervical area.On intraoral examination revealed no abnormalities, no swelling and infection.There was no area of drainage intra or extraoral.After microdermabrasion by cosmetologist.She was left with an excoriation over the right malar eminence.The physician suspected the event biofilm related infection considering pt's skin and partial response to antibiotics.According to the physician, course of long term antibiotics will be beneficial for pt and pt should discontinue the steroid therapy and also she should have mri of the cheeks and biopsy.Follow-up info received on (b)(6) 2013.Medical history updated with internal hemorrhoids, non-smoker and abstains from alcohol.Follow-up info received on (b)(6) 2013: concomitant medications updated.Follow-up info received via medical records and legal documents on (b)(6) 2014: new events of granulomas palpable in cheeks, lumps on the face (bilateral cheek, infra-orbital areas), insomnia, masses under the skin, redness, inflammation, headaches, solidified foreign body production and material (not limited to but especially around cheek, including, but not limited to granulomas) and quality of life loss added.Therapy date added.Follow-up info received via medical records and pharmacy records on (b)(6) 2014: concomitant medications of levaquin, nitrofurantoin mono-mcr 1, amlodipine besylate, halflytely and bisacodyl bowel prep kit, acetic acidhc ear drops, factive, truvada, amlodipine/benazepril added.This case was received by sanofi-aventis via medical records and forwarded to valeant on (b)(6) 2013.Follow-up was received by sanofi-aventis via medical records on (b)(6) 2013 and forwarded to valeant on (b)(6) 2013.Follow-up was received by sanofi-aventis via medical records on (b)(6) 2013 and forwarded to valeant on (b)(6) 2013.Follow-up was received by sanofi-aventis via medical records on (b)(6) 2013 and forwarded to valeant on (b)(6) 2013.Follow-up was received via medical records on (b)(6) 2013 and forwarded to valeant on (b)(6) 2013.Follow-up was received via medical records on (b)(6) 2014 and forwarded to valeant on (b)(6) 2014.Follow up was received via medical records on (b)(6) 2014 and forwarded to valeant on (b)(6) 2014.
 
Manufacturer Narrative
Pharmacovigilance comment: pb (b)(6) 2013: swelling face, nodule, hypoaesthesia, scar assessed as serious and possibly related.Pb (b)(6) 2013: no change to previous medical assessments.Pb (b)(6) 2013: new event infection assessed as serious and possibly related.No change to previous medical assessments.Pb (b)(6) 2013: no change to previous medical assessment.Pb (b)(6) 2013: no change to previous medical assessment.On (b)(6) 2014: event of granuloma, injection site mass, insomnia, skin mass, erythema, inflammation, headache, foreign body, quality of life decreased added and assessed as serious and possibly related.
 
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Brand Name
SCULPTRA, POLY-L-LACTIC ACID
Type of Device
INJECTABLE DERMAL FILLER
Manufacturer Contact
700 route 202/206 north
bridgewater, NJ 08807
4416285665
MDR Report Key3690556
MDR Text Key17840786
Report Number3009443653-2014-00104
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 09/09/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/14/2014
Initial Date FDA Received03/14/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ARTHROTEC, 75MG, TABLET; 160MG/12.5MG, TAKE ONE AT BEDTIME, ORAL; LEVAQUIN (LEVOFLOXACIN), 500MG, TABLET; 875MG, 2 IN 1 DAY, ORAL; (BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESILATE),; 5MG, 1 IN 1 DAY; CRESTOR (ROSUVASTATIN CALCIUM), 5MG, TABLET,; (40MG, CAPSULE), 40MG, 1 IN 1 DAY, ORAL; ACETIC ACID, EAR DROPS; NEXIUM (ESOMERAZOLE MAGNESIUM),; DIOVAN HCT (CO-DIOVAN), TABLET,; AMLODIPINE BENAZEPRIL (COROVAL B),; (HYDROCHLOROTHIAZIDE, VALSARTAN), 160/12.5MG,; AS DIRECTED; CIPRO HC OTIC, 10MLS, SUSPENSION,; MELOXICAM, 15MG, TABLET, 1 TABLET DAILY FOR,; METRONIDAZOLE, 500MG, TABLET,; (CLAVULANATE POTASSIUM, AMOXICILLIN TRIHYDRATE),; DIOVAN (COROVAL B) (160 MG, TABLET); FACTIVE (GEMIFLOXACIN MESILATE) 320MG, TABLET; 20MG, 1 IN 1 DAY, ORAL; HYDROCHLORIDE), 15MG/500MG, 1 IN 1 DAY, ORAL; SODIUM CHLORIDE, MACROGOL 3350); CAPSULE, 250MG, 2 IN 1 DAY; (DICLOFENAC SODIUM, MISOPROSTOL), 2 IN 1 D, ORAL; 37.5-25MG, 1 IN 1 DAY; VALSARTAN/HCTZ (CO-DIOVAN), TABLET, 160MG/12.5MG,; (SODIUM BICARBONATE, BISACODYL, POTASSIUM CL,; CIPROFLOXACIN, 500MG, TABLET, 2 IN 1 DAY, ORAL; (HALFLYTELY & BISACODYL BOWEL PREP KIT),; 160MG; ACTOPLUS MET (MOPADAY), TABLET,; PREDNISONE, 10MG, TABLET, TAKE AS DIRECTED; TRUVADA (200-300MG TABLET),; 160/12.5MG EVERY NIGHT AT BEDTIME, ORAL; NITROFURANTOIN MONO-MCR 1,; 14 DAYS THEN 1/2 TABLET DAILY, ORAL; AMLODIPIINE BESYLATE, 5MG; 10 DROPS IN BOTH EARS 2 X A DAY, AURICULAR (OTIC); ATORVASTATIN, 20MG TABLET, 20MG, 1 IN 1 DAY, ORAL; TRIAMTERENCE-HCTZ (DYAZIDE), TABLET,; FLORASTOR (SACCHAROMYCES BOULARDII), 250MG,; (NITROFURANTOIN MONOHYDRATE); HALFLYTELY-BISACOYDYL,; 1 TABLET 3 TIMES DAILY WITH FOOD, ORAL; LIPITOR (ATORVASTATIN CALCIUM), 20MG, TABLET,; NAFTIN (NAFTIFINE HYDROCHLORIDE), 1% GEL; METFORMIN, 500MG, TABLET; ACTOS (PIOGLITAZONE HYDROCHLORIDE), 15MG, TABLET; (HYDROCORTISONE, CIPROFLOXACIN, HYDROCHLORIDE),; AZITHROMYCIN, 250MG, TABLET; TRETINOIN, 0.05%, CREAM, AS DIRECTED; TAMIFLU (OSELTAMIVIR PHOSPHATE), 75MG, CAPSULE,; 5-325MG, 1-2 EVERY 4 HOURS AS NEEDED FOR PAIN; (PARACEMTAMOL, OXYCODONE, HYDROCHLORIDE),; OXYCODONE/ACETAMINOPHEN (OXYCOCET), TABLET,; AMOXICILLIN, 500MG, CAPSULE; (METFORMIN HYDROCHLORIDE, PIOGLITAZONE,; PRAVASTATIN SODIUM (PRAVASTATIN SODIUM), 10MG; AMOX-CLAV (SPEKTRAMOX), 875MG, TABLET,; (BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESILATE); (EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE)
Patient Outcome(s) Other; Disability;
Patient Age68 YR
Patient Weight64
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