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

Lot Number 1J1954

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

Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888); Necrosis (1971); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545); Implant Pain (4561)

Event Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2021 by a physician concerning a female patient of an unknown age. No information about medical history, history of allergies or previous filler treatments has been provided. On unknown date, the patient received treatment with sculptra to buttock (unknown amount, lot number, injection technique and needle type). The sculptra was diluted with 16 ml of unspecified solution and lidocaine [lidocaine], but it was unknown if it was with or without epinephrine. The patient experienced pain (implant site pain) during sculptra injection. On an unknown date, the patient also experienced skin color and appearance alteration (implant site discolouration) and skin necrosis (implant site necrosis). As a corrective treatment, the necrotic skin was removed. The patient also received medication treatment with unspecified antibiotics and anti-inflammatories since the onset of the skin disorder. Outcome at the time of the report: skin necrosis was not recovered/not resolved/ongoing. Pain was not recovered/not resolved/ongoing. Skin color and appearance alteration was not recovered/not resolved/ongoing. Tracking list: initial report sent on (b)(6) 2021, where skin lesion was reported and the event had been improved with treatments (antibiotics and anti-inflammatories). Initial version assessed was non-serious. Follow-up information was received on (b)(6) 2021: skin lesion was updated to skin necrosis and additional events were reported. Events were still ongoing. Case was upgraded to serious based on surgical and medical intervention to prevent permanent damage.

Manufacturer Narrative

Company comment: the serious event of necrosis at implant site and the non-serious events of pain and discolouration at implant site were considered expected and possibly related to the treatment. Serious criteria include the need for surgical and medical intervention to prevent permanent damage. The potential root cause include filler injection intravascularly or in the vicinity of blood vessels leading to vascular occlusion or compression and subsequent manifestations of ischaemia and necrosis at implant site. Potential contributory factor include injection technique. The case meets the criteria for expedited reporting to the regulatory authorities. Evaluation text: sculptra-routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure. Lot number was not reported and the product could not be verified. The information in this case does not indicate a non-conforming product or malfunction. The performed investigations are therefore considered adequate and no additional investigations will be conducted. Capa comment: sculptra-no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.

Manufacturer Narrative

Company comment: the serious event of necrosis at implant site and the non-serious events of pain and discolouration at implant site were considered expected and possibly related to the treatment. Serious criteria include the need for surgical and medical intervention to prevent permanent damage. The potential root cause include filler injection intravascularly or in the vicinity of blood vessels leading to vascular occlusion or compression and subsequent manifestations of ischaemia and necrosis at implant site. Potential contributory factor include injection technique. The case meets the criteria for expedited reporting to the regulatory authorities. Evaluation text: sculptra-routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure. Lot number was not reported and the product could not be verified. The information in this case does not indicate a non-conforming product or malfunction. The performed investigations are therefore considered adequate and no additional investigations will be conducted. Capa comment: sculptra-no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2021 by a physician concerning a female patient of an unknown age. No information about medical history, history of allergies or previous filler treatments has been provided. On unknown date, the patient received treatment with sculptra to buttock (unknown amount, lot number, injection technique and needle type). The sculptra was diluted with 16 ml of unspecified solution and lidocaine [lidocaine], but it was unknown if it was with or without epinephrine. The patient experienced pain (implant site pain) during sculptra injection. On an unknown date, the patient also experienced skin color and appearance alteration (implant site discolouration) and skin necrosis (implant site necrosis). As a corrective treatment, the necrotic skin was removed. The patient also received medication treatment with unspecified antibiotics and anti-inflammatories since the onset of the skin disorder. Outcome at the time of the report: skin necrosis was not recovered/not resolved/ongoing. Pain was not recovered/not resolved/ongoing. Skin color and appearance alteration was not recovered/not resolved/ongoing. Tracking list: initial report sent on (b)(6) 2021, where skin lesion was reported and the event had been improved with treatments (antibiotics and anti-inflammatories). Initial version assessed was non-serious. Follow-up information was received on (b)(6) 2021: skin lesion was updated to skin necrosis and additional events were reported. Events were still ongoing. Case was upgraded to serious based on surgical and medical intervention to prevent permanent damage.

• Brand Name: SCULPTRA
• 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 n. freeway; fort worth, TX 76177
• MDR Report Key: 13225421
• MDR Text Key: 285458964
• Report Number: 9710154-2022-00001
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P030050S002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: 1J1954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• 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: 01/11/2022 Patient Sequence Number: 1

Treatment

LIDOCAINE.; LIDOCAINE.; STERILE WATER FOR INJECTION.