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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALDERMA Q-MED NEW-FILL IMPLANT, DERMAL, FOR AESTHETIC USE

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GALDERMA Q-MED NEW-FILL IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Pain (1994); Skin Inflammation (2443); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Pharmacovigilance comment: the serious expected event of nodule at implant site was considered possibly related to the treatment. Serious criteria include the need for multiple intervention and permanent damage or disability (at 48 months during follow up the patient had recurrent episode of nodule). The non-serious events of inflammation, pain and oedema at implant site were considered expected and possibly related to the treatment. Potential contributory factor includes injection technique. The case meets the criteria for expedited reporting to the regulatory authorities. Capa comment: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action. This case was received late by the pv department and is included in the investigation of (b)(4). Lot number was not reported.
 
Event Description
Case reference number (b)(4) is a literature report detected on 01-oct-2019 by medical affairs department during a literature screening. This case was identified from the literature article alijotas-reig j, garcia-gimenez v, vilardell-tarres m. Late-onset immune-mediated adverse effects after poly-l-lactic acid injection in non-hiv patients: clinical findings and long-term follow-up. Dermatology: 01-oct-2009:(219):303-308. A (b)(6) female patient received treatment with new-fill (plla) to glabella, lips. 6 months later treatment with new-fill, the patient developed painful, inflammatory nodules and severe localized or generalized facial oedema. Biopsy of lesions was not mandatory but requested. Corrective treatments included ibuprofen 1,800-2,400 mg/day and combination therapy including intralesional steroids i. E. Betamethasone (each vial contains 3 mg of betamethasone phosphate and 3 mg of betamethasone acetate in a total volume of 2 ml). According to the size and inflammatory aspect of the nodules, injected betamethasone, ranging from 0. 1 to 0. 5 ml/nodule, usually with no dilution. The patient had recurrent inflammatory bouts but with different intensities. During follow up 48 months later, there was recurrent bouts with clinical findings of facial oedema and nodules.
 
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Brand NameNEW-FILL
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer (Section G)
GALDERMA Q-MED
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer Contact
randy russell
14501 n. freeway
fort worth, TX 76177
8179615146
MDR Report Key9722262
MDR Text Key192452702
Report Number9710154-2020-00028
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P030050/S2
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2019
Was Device Evaluated by Manufacturer? No
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: 02/18/2020 Patient Sequence Number: 1
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