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

Lot Number A4077

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ecchymosis (1818); Granuloma (1876); Subcutaneous Nodule (4548); Swelling/ Edema (4577)

Event Date 04/01/2015

Event Type  Injury  

Manufacturer Narrative

Product note: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure. The reported lot number was valid and verified the reported product. The information in this case does not indicate a nonconforming product or malfunction. Investigations including documentation review of the analysis certificate at release step of sculptra batch a4077 has been re-checked and all the results complied with specifications. Moreover, both the supplier certificate of analysis and the internal certificate of analysis relevant to the lots of blanose cmc (code 85010624 batch an103865), plla (code 85010219 batch an112003) and mannitol (code 85000112 batch an106983) utilized in the manufacturing of sculptra batch a4077 have been re-controlled and all the results were conforming with the specifications limits. We have re-checked also the batch record of sculptra lot a4077; no anomalies impacting the quality of the product released for the market were identified. The performed investigation are therefore considered adequate and no additional investigations will be conducted. Company comment: the serious events of mass, swelling at implant site, granuloma skin and the non-serious event of bruising at implant site were considered expected and possibly related to the treatment. Serious criteria include the need for multiple medical interventions and long standing events suggestive of permanent damage. Potential root causes include treatment procedure or a foreign body reaction to the product in the local tissue. The case meets the criteria for expedited reporting to the regulatory authorities.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 14-jul-2015 by a (b)(6) female patient, concerning herself. No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided. On (b)(6) 2014, the patient received treatment with 3 vials sculptra aesthetic (lot a4077) to the cheeks and area around the eyes with unknown injection technique and needle type. Unknown time later, on an unknown date in (b)(6) 2015, the patient experienced harder lumps (implant site mass) and swelling (implant site swelling). On (b)(6) 2015, the patient reported that she thinks the physician injected her immediately after reconstitution rather than allow the product to hydrate over 2 hours. On (b)(6) 2015, the patient called back and stated that the lumps were worse. The patient still felt the lumps underneath her skin where she was injected and currently, there were more lumps. She also said the lumps were harder. The patient stated she was bruised (implant site bruising) for about 1 month after the injection as well. The patient would be following up with her doctor on (b)(6) 2015. As per follow up report received on 11-nov-2015, the patient reported she had applied cold compress to alleviate symptoms of the events. The patient contacted their health care provider on an unspecified date and received [triamcinolone acetonide] injections. At the time of the report the patient had not recovered. As per follow up report received on 21-jul-2021, the patient reported that she had seen approximately 25 doctors since 2014 to treat her granulomas (granuloma skin) with massage, saline [sodium chloride], kenalog and 5-fu [5-fu] but nothing has helped. There had been minimal improvements. Outcome at the time of the report: harder lumps was not recovered/not resolved/ongoing. Swelling was not recovered/not resolved/ongoing. Granulomas was not recovered/not resolved/ongoing. Bruised was recovered/resolved. Tracking list: v. 0 initial. V. 1 fu received on 26-aug-2015 from the patient. Concerning dosage and administration and reconstitution of the product and narrative was updated. V. 2 fu received on 24-sep-2015 from the patient. Events harder and bruised were added and narrative was updated. V. 3 fu received on 02-nov-2015 from the patient. Volume of sculptra aesthetic and narrative was updated. V. 4 fu received on 11-nov-2015 from the patient. The dosage, implant site date, device location of sculptra aesthetic was updated. The adverse event swelling was added. The corrective treatment cold compress to alleviate symptoms of the events and kenalog injections and outcome of the events were updated. V. 5 fu received on 21-jul-2021 from the patient. Case upgraded to serious. Event (granulomas) added. Verbatim of lumps updated to harder lumps. Corrective treatments saline and 5fu were added.

• Brand Name: SCULPTRA AESTHETIC
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 north freeway; fort worth, TX 76177
• MDR Report Key: 12319657
• MDR Text Key: 273544163
• Report Number: 9710154-2021-00055
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030050S002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: A4077
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/21/2021
• 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: Unkown

Patient Treatment Data

Date Received: 08/13/2021 Patient Sequence Number: 1