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U.S. Department of Health and Human Services

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

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GALDERMA Q-MED AB RESTYLANE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Lot Number 15276
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Hyperplasia (1906); Discomfort (2330); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/01/2020
Event Type  Injury  
Manufacturer Narrative
Pharmacovigilance comments: the serious expected event of swelling at implant site and the non-serious expected events of erythema at implant site, discomfort at injection site and unexpected event of hyperplasia were considered possibly related to the treatment. Serious criteria include the need for multiple medical, surgical interventions. The reporter suspected that counterfeit restylane was used, however the reported lot number is valid for restylane. Potential root causes for the events include reaction to the product in the local tissue. It was difficult to determine if permanent damage had occurred since inflammation associated with the multiple corrective procedures and surgery might have contributed to reversible swelling, and the other events were resolving. The case meets the criteria for expedited reporting to the regulatory authorities. Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations. Manufacturer narrative: 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 non-conforming product or malfunction. A brr revealed no potential quality issues have been identified in the manufacturing process of the specified batch. The batch is manufactured and released according to galderma quality management system.
 
Event Description
Case reference number (b)(4) is a spontaneous report sent on 13-jul-2020 by a female patient of an unknown age concerning about herself via an other health professional. The case narrative contains additional information received on 03-oct-2020 and 07-oct-2020. The patient had no allergies. No information about medical history, concomitant medication or previous filler treatments has been provided. On an unknown date in (b)(6) 2018, the patient received treatment with 6 ml restylane (lot 15276) to jaw, nasolabial folds with unknown injection technique and needle type. Unknown time later, on an unknown date in (b)(6) 2020, the patient experienced erythema(implant site erythema) and hyperplasia(hyperplasia) at jaw and face. The patient suspected the authenticity of the product/product was counterfeit(suspected counterfeit product). So the hcp wanted to know how to confirm whether the product was counterfeit or not. The patient went to the hospital to have an mri, facial ct, which showed that there was still restylane residue, and the patient was not injected with other products. The patient still felt that the jaw got bigger and the face was swollen (implant site swelling) and uncomfortable (injection site discomfort). The patient had received lytic enzymes injection under the jaw and the apple muscle for treatment on (b)(6) 2020, and the symptoms were slowly relieved. The patient would be injected lytic enzymes under both areas of the face, temples and so on in the future. As per follow up information received on 04-feb-2021, the patient was injected with lytic enzymes about ten times by (b)(6) 2021 and underwent surgery of general anesthesia. The patient still experienced swelling with residues on face, and the reporter suspected that the product was counterfeit. Outcome at the time of the report: swollen was not recovered/not resolved. Erythema was recovering/resolving. Hyperplasia was recovering/resolving. Uncomfortable was recovering/resolving. Suspected the authenticity of the product/product was counterfeit was recovered/resolved. Tracking list: v. 0 initial. V. 1 fu received on (b)(4) 2020, (b)(4) 2020 and (b)(4) 2020 from the same reporter: patient demographics, event start date, event location and outcome of the events updated. Lab test, new non serious event of injection site discomfort and implant site swelling were added. V. 2 fu received on (b)(6) 2021 from patient via hcp: case upgraded to serious. Suspect device lot number and outcome of event swelling updated.
 
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Brand NameRESTYLANE
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 Key11385867
MDR Text Key243727927
Report Number9710154-2021-00010
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P040024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2020
Device Lot Number15276
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2017
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: 02/26/2021 Patient Sequence Number: 1
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