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

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

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.

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.

• Brand Name: SCULPTRA AESTHETIC
• Type of Device: IMPLANT, 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 Key: 7039098
• MDR Text Key: 92303621
• Report Number: 9710154-2017-00095
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030050/S2
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• 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 Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: A6110
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2017
• Distributor Facility Aware Date: 11/29/2017
• Date Report to Manufacturer: 11/29/2017
• Date Manufacturer Received: 11/29/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR