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 Foreign Body Reaction (1868); Skin Inflammation (2443)

Event Type  Injury  

Manufacturer Narrative

Lot number was not reported.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).Pharmacovigilance comment: the serious event of foreign body reaction and the non-serious event of inflammation at implant site were considered expected and possibly related to the treatment.Serious criteria include the need for multiple medical interventions and surgical intervention in form of nodule excision.Potential contributory factors include injection technique.The case meets the criteria for expedited reporting to the regulatory authorities.

Event Description

Case reference number (b)(4) is a literature report detected on 03-jun-2017 by the medical affairs department during a literature screening.This case was identified from the literature article apikian m, roberts s, goodman gj.Adverse reactions to polylactic acid injections in the periorbital area.J cosmet dermatol.2007 jun;6(2):95-101.A healthy, (b)(6) anglo-saxon woman presented for correction of bilateral lower eyelid and cheek contour deformity and rhytides in the orbital areas.In one treatment session, patient received five injections each of 0.1 ml of new-fill (pla) in each infra-orbital areas, as well as 0.5 ml of pla in the temporal areas bilaterally and 0.6 ml in the cheek area bilaterally.The new-fill was diluted with three milliliters of water for injection and 1 ml of epinephrine-free lidocaine were added to each vial using a sterile 18-gauge needle.All vials were prepared at least 2 hours before use.Injections were done with a 26-gauge luer-lock syringe.All areas injected were disinfected with an alcohol swab immediately before injection.The injected areas were all massaged immediately after procedure to ensure uniform distribution of the product.On review, 6 weeks post-treatment, several firm 1- to 2-mm asymptomatic nodules in the infra-orbital areas were apparent upon examination.According to the patient, these had arisen 4 weeks post treatment.The nodules were aesthetically distressing to the patient who requested further intervention.Corrective treatment included oral prednisolone, 25 mg daily for 7 days, as well as topical methylprednisolone aceponate cream, 0.1 percent once daily (advantan) was prescribed.Two months later, the nodules remained unchanged.Intra-lesional steroid injections were done: 1 ml of betamethasone, 5.7 mg as betamethasone sodium phosphate 3.9 mg (in solution) and betamethasone acetate 3 mg (in suspension; celestone chronodose), in both infra-orbital areas.Review of the patient 7 months post-treatment failed to reveal any improvement in the appearance of the nodules.Skin biopsies of the nodules were undertaken.Histopathology revealed a foreign-body granulomatous inflammatory reaction consisting of a collection of foreign material that was polarizable and birefringent, surrounded by macrophages and multinucleated giant cells.Within 2 weeks of the biopsies, the patient had complete healing.The remaining nodules were subsequently surgically excised.Follow-up revealed the patient to be free of further disfiguring nodules in this area.

• 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: 9708032
• MDR Text Key: 192442762
• Report Number: 9710154-2020-00026
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• 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: 06/03/2017
• 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
• Patient Age: 49 YR