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 Abscess (1690); Erythema (1840); Granuloma (1876); Unspecified Infection (1930); Pain (1994); Swelling (2091); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious, expected events of abscess and infection at the implant site, granuloma skin, and the unexpected event of alpha haemolytic streptococcal infection were considered possibly related to the treatment.Serious criteria include the need for medical and surgical interventions to prevent permanent damage.The non-serious events of pain, erythema and swelling at the implant site were considered expected and possibly related to the treatment.Potential contributory factors 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 03-jun-2017 by the medical affairs department during literature screening.In this case, the physician refers to a (b)(6) female patient.This case was identified from the literature article goldan o, garbov-nardini g, regev e, orenstein a, winkler e.Late-onset infections and granuloma formation after facial polylactic acid (new-fill) injections in women who are heavy smokers.Plast reconstr surg.2008;121(5):336-338.We treated four patients with late-onset infection and granuloma formation after new-fill facial injection.Two of the patients presented with serious infectious complications.All four patients were healthy women who were heavy smokers; they had a mean age of 48 years and had been injected with new-fill approximately 2 to 6 months before admission to our department.Their presenting symptoms were pain, swelling, and erythema at the injection site.Furthermore, nodules representing granuloma formation were palpable under the skin or the lip vermilion in all patients.Before their admission, three of the four patients were treated with local steroid injections without relief of symptoms.Our treatment consisted primarily of antibiotic therapy.One patient, a (b)(6) woman (refers to this case) after new-fill injections to the lower lip and nasolabial folds presented with multifocal abscesses, with isolation of streptococcus viridans, requiring recurrent surgical drainage.All patients experienced persistent granulomas, despite antibiotic and local steroid therapy.

• 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: 9722322
• MDR Text Key: 192495681
• Report Number: 9710154-2020-00030
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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

• 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
• Initial Date Manufacturer Received: 06/03/2017
• Initial Date FDA Received: 02/18/2020
• 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: 47 YR