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U.S. Department of Health and Human Services

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

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GALDERMA Q-MED AB SCULPTRA IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
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.
 
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Brand NameSCULPTRA
Type of DeviceIMPLANT, 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 Key13225421
MDR Text Key285458964
Report Number9710154-2022-00001
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
P030050S002
Number of Events Reported1
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 Received01/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number1J1954
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2022
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.
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