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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALDERMA QMED SCULPTRA AESTHETIC IMPLANT, DERMAL, FOR AESTHETIC USE

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GALDERMA QMED SCULPTRA AESTHETIC IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Lot Number A6110
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Granuloma (1876); Skin Inflammation (2443); No Code Available (3191)
Event Date 08/01/2017
Event Type  Injury  
Manufacturer Narrative
Manufacturer narrative: a trend analysis shows that there are no increased trends of medical complaint for the reported lot number a6110. Pharmacovigilance comment: the serious event of granuloma, and the non-serious events of abscess and inflammation at the implant site were considered possibly related to the treatment procedure. The non-serious, unexpected event of granulation tissue was also considered possibly related to the treatment. Serious criteria included the need for surgical lumpectomy, biopsy and steroid injection. Potential contributory factors for the giant cell granulomas include the presence of inflammation and infection and previous sculptra treatments. The granulation tissue represented the wound healing process for these events. The case report meets the seriousness and causality criteria that require expedited reporting to the health authority. Engineering evaluation: no corrective or preventive action will be initiated. (b)(4).
 
Event Description
Case reference number (b)(4) is a spontaneous report sent on 02-nov-2017 by a registered nurse (rn) which refers to a female aged (b)(4) years. She had a fitzpatrick skin type i-ii. Medical history was within normal limits, and no concomitant treatments or allergies were reported. The patient had previously received two treatments with sculptra aesthetic to unreported areas. On (b)(6) 2017, the patient received treatment with 16 ml (1 vial to each cheek area) sculptra aesthetic (lot a6110) to face, cheek with a 25 gauge cannula and unknown technique. On (b)(6) 2017, the patient experienced an abnormal lump/giant cell granulomas(granuloma) at the right side of the mid-cheek area. On (b)(6) 2017 the patient was injected with 0. 1ml of kenalog [triamcinolone acetonide] with a temporary reduction of inflammation. The rn was suspicious of it, so it was removed and a biopsy was performed on (b)(6) 2017. The pathology report stated it was granulation tissue. The results of the biopsy were: superficial dermal abscess (implant site abscess) with granulation tissue (excessive granulation tissue), chronic inflammation (implant site inflammation) and giant cell granulomas (granuloma); it was found to be non-malignant. Treatment for the adverse event included: kenalog injection, excision of lump. Reporter causality: possible for both injection and substance. The reported the case as serious as to permanent damage to a body structure and condition necessitating surgical intervention. Outcome at the time of the report: lump/giant cell granulomas was recovered/resolved. Chronic inflammation was recovered/resolved. Superficial dermal abscess was recovered/resolved. Granulation tissue was recovered/resolved. Tracking list: v. 1 29-nov-2017: fitzpatrick skin type, medical history allergy update, needle, onset and resolution dates of event, severity, causality, dates of treatment and outcome, pathology report additional findings.
 
Manufacturer Narrative
A trend analysis shows that there are no increased trends of medical complaint for the reported lot number a6110. Pharmacovigilance comment: the serious event of granuloma, and the non-serious events of abscess and inflammation at the implant site were considered possibly related to the treatment procedure. The non-serious, unexpected event of granulation tissue was also considered possibly related to the treatment. Serious criteria included the need for surgical lumpectomy and biopsy. Potential contributory factors for the giant cell granulomas include the presence of inflammation and infection and previous sculptra treatments. The granulation tissue represented the wound healing process for these events. The case report meets the seriousness and causality criteria that require expedited reporting to the health authority. Engineering evaluation: no corrective or preventive action will be initiated. (b)(4).
 
Event Description
(b)(4) is a spontaneous report sent on 02-nov-2017 by a registered nurse (rn) which refers to a female (b)(6). Medical history, concomitant treatments, and allergies were not reported. The patient had previously received two treatments with sculptra aesthetic to unreported areas. On (b)(6) 2017, the patient received treatment with 16 ml (1 vial to each cheek area) sculptra aesthetic (lot a6110) to face, cheek with unknown needle and unknown technique. Two to three (2-3) weeks later, the patient experienced an abnormal lump/giant cell granulomas(granuloma) at the right side of the mid-cheek area. The rn was suspicious of it, so it was removed and a biopsy was performed. The results of the biopsy were: superficial dermal abscess (implant site abscess) with granulation tissue (excessive granulation tissue), chronic inflammation (implant site inflammation) and giant cell granulomas (granuloma); it was found to be non-malignant. Treatment for the adverse event removal of lump. Outcome at the time of the report: lump/giant cell granulomas was recovered/resolved. Chronic inflammation was recovered/resolved. Superficial dermal abscess was recovered/resolved. Granulation tissue was recovered/resolved.
 
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Brand NameSCULPTRA AESTHETIC
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA QMED
seminarigatan 21
upsala, se-752 28 SE-75 2 28
SW SE-752 28
Manufacturer Contact
lisa bernaise
seminarigatan 21
upsala, se-752 28 SE-75-2 28
SW   SE-752 28
MDR Report Key7039098
MDR Text Key256205241
Report Number9710154-2017-00095
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030050/S2
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberA6110
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/14/2017
Distributor Facility Aware Date11/29/2017
Event Location No Information
Date Report to Manufacturer11/29/2017
Date Manufacturer Received11/29/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/16/2017 Patient Sequence Number: 1
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