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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALDERMA Q-MED SCULPTRA AESTHETIC IMPLANT, DERMAL, FOR AESTHETIC USE

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GALDERMA Q-MED SCULPTRA AESTHETIC IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Bacterial Infection (1735); Cyst(s) (1800); Granuloma (1876); Hypersensitivity/Allergic reaction (1907); Swelling (2091); No Code Available (3191)
Event Date 03/20/2018
Event Type  Injury  
Manufacturer Narrative
Pharmacovigilance comments: the serious, expected events of skin granuloma and injection site cyst were considered possibly related to the treatment. Serious criteria included the need for medical intervention to prevent permanent harm, including multiple antibiotics and systemic steroids. The non-serious, expected event of face swelling was considered possibly related to the treatment. Potential contributory factors for the event of granuloma and cyst include inflammation and infection from the treatment procedure. The event of cyst is likely associated with granuloma which is labeled in the instructions for use. The case meets the seriousness criteria for expedited reporting to the regulatory authorities. Engineering evaluation: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action. Manufacturer narrative: lot number was not reported. (b)(4).
 
Event Description
Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2018 by a physician referring to a (b)(6) female patient. Additional information received on (b)(6) 2018 was included in this report. The patient is a eye prosthesis user since she was five years old and has no concomitant medications. The patient had previously received treatment with restylane perlane on (b)(6) 2013 (nasogenian sulcus), emervel volume (each side of lacrimal gut) and emervel classic (left and right nasogenian sulcus) in (b)(6) 2016. On an unknown date the patient received her first treatment with sculptra. Approximately on (b)(6) 2018, the patient received her second treatment with sculptra to the temples, malar, lateral and proximal fat pad area, and 0. 3 ml in the left and right piriform fossa. The lot no. , total amount used, injection technique and needle type were unknown. It was reported that the treatments with sculptra were performed outside of emervel's previous injection sites and without intercurrences. On (b)(6) 2018, the patient experienced swelling face(swelling face) and got a visible cyst(injection site cyst) (approximately 10 cm) in the contour of the injection sites. On the same date, the patient sent photos to the physician that showed a left face enlargement. The patient received a prescription of loratadine [loratadine] for oral use. In (b)(6) 2018, the patient visited the physician. At the examination the physician visualized a picture of cystic lesion, more palpable than visible with fibroelastic consistency and absence of phlogistic signs in the left nasogenian sulcus. On (b)(6) 2018, the patient underwent an ultrasonography which showed a cystic lesion of about 5. 0 ml of content in the left nasogenian sulcus. On (b)(6) 2018, a puncture of the lesion was performed where the contents were described as a serous yellow-dark liquid. On an unknown date, the patient received corrective treatment with clarithromycin [clarithromycin], ciprofloxacin [ciprofloxacin] and systemic corticosteroid [corticosteroids for systemic use] in the last three days (as reported). A cytology test of the punctured fluid was performed which showed giant cell histiocytic and neutrophil granulomatous reaction(granuloma skin). The physician reported that the cyst was improving, because when it appeared it was visible, but currently it was only palpable. Outcome at the time of the report: swelling face was unknown. Cyst was recovering/resolving. Giant cell histiocytic and neutrophil granulomatous reaction was unknown.
 
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Brand NameSCULPTRA AESTHETIC
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer (Section G)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer Contact
amy poteate
14501 north freeway
fort worth, TX 76177
8175615353
MDR Report Key7491880
MDR Text Key107531832
Report Number9710154-2018-00032
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P030050/S2
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/07/2018 Patient Sequence Number: 1
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