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

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 event of nodule at implant site was considered expected and possibly related to the treatment.Serious criteria included the need for multiple medical interventions and permanent damage or disability (at follow up 60 months later the patient had recurrent nodule).The non-serious events of pain, inflammation and oedema at implant site were considered expected and possibly related to the treatment.Potential contributory factor include 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 nasolabial folds.The patient had previously received treatment with bio-alcamid filler 12 months before plla was injected.12 months later treatment with new-fill, the patient developed painful, inflammatory nodules and severe localized or generalized facial oedema, bilateral sometimes.Biopsy of lesions was not mandatory but requested.Corrective treatments included ibuprofen (1,800-2,400 mg/day), oral prednisone (0.2-0.5 mg/kg/day), hydroxychloroquine (6 mg/kg/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.During follow up 60 months later the patient had recurrent bouts with clinical findings of inflammatory nodules.

• Brand Name: NEW-FILL
• Type of Device: IMPLANT, 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 Key: 9722271
• MDR Text Key: 192497540
• Report Number: 9710154-2020-00029
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030050/S2
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• 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 Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 50 YR