MAUDE Adverse Event Report: GALDERMA Q-MED UNSPECIFIED PLLA FILLER; 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); No Code Available (3191)

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 expected event of foreign body reaction was considered possibly related to the treatment.Serious criteria included the need for medical, surgical intervention and long standing event of 26 months duration suggestive of permanent damage.The non-serious, expected events of cutaneous contour deformity and inflammation at implant site were considered possibly related to the treatment.Potential contributory factors include injection technique or over correction.The case meets the criteria for expedited reporting to the regulatory authorities.

Event Description

Case reference number (b)(4) is a literature report received on 01-oct-2019 from an other healthcare professional concerning a (b)(6) female patient.This case was identified from the literature article chang ch, park th,yeo kk, seo sw, kim j, lee jh et al.Clinical experience with complications of hand rejuvenation.J plast reconstr aesthet surg 2012;65(12):1627-33.Patients and methods: a retrospective chart review was performed for a period of 10 years from march, 2001 to january, 2011.We compiled and analysed data for 15 patients who underwent surgical excisions or injection therapies for the treatment of a foreign body granuloma of the hand at our hospital.We reviewed patient's symptoms, sex, age, interval between the time of injection to the first visit, previous treatment history, injection materials, treatment methods and clinical photographs.In all patients, a follow-up period of 2 months was required.The results were assessed objectively using serial photography and subjectively according to patient assessment.For objective assessment, two physicians who were not involved in the surgeries assessed surgical outcomes using serial photography.For subjective assessment, the results were evaluated by the patients based on postoperative satisfaction ratings on a five-point scale 2 months after the second operation.The patients were asked to rate their overall satisfaction with their scar revision as very satisfied (5), satisfied (4), neutral (3), dissatisfied (2) or completely dissatisfied (1).All statistical analyses were conducted using pasw version 18.0 (ibm, armonk, new york, usa).The descriptive statistics are presented as both numbers and percentages of patients or as means and standard deviations (or ranges).Results: only one patient (1/15, 6.7%) was not satisfied with the outcomes after treatment of hand rejuvenation complications, two were very satisfied (13.3%), seven were satisfied (46.7%), five were neutral (33.3%), none were dissatisfied (0%) and one was completely dissatisfied (6.7%).Consensus ratings by the two independent physicians revealed that objective outcomes were divided between 'very much improved', 'significantly improved' and 'no change'.No outcomes were rated as 'significantly worse' or 'very much worse'.All plastic surgeons recognized that postoperative appearance was improved after treatment of hand rejuvenation complications; eight were considered very much improved (53.3%) and six were considered significantly improved (46.7%).In this study, we administered various treatment methods, including the application of ice, massage, hand elevation, antibiotics, topical steroids, hyaluronidase injections, intralesional steroid injection and surgical excision.Our initial antibiotic regimen consisted of at least a two-drug therapy, such as a second-generation cephalosporin and a third-generation macrolide, for 7 days.After a trial of antibiotics, intralesional steroids (40 mg ml_1, total of two injections) should be considered when injected with various medical fillers, except calcium hydroxyapatite (caha) and hyaluronic acid ha) fillers.The steroids should be injected in the same plane as the filler injection.On an unknown date, the patient received treatment with unspecified plla filler (unknown amount, lot number, injection technique and needle type) to hand for rejuvenation.On an unknown date, unknown time later, the patient experienced inflammatory symptoms (implant site inflammation), contour deformity (cutaneous contour deformity) and foreign body granuloma (foreign body reaction) at hand with 26 months duration.Treatment for the adverse event included surgical excision and intralesional steroid injection.

• Brand Name: UNSPECIFIED PLLA FILLER
• 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: 9708029
• MDR Text Key: 192450689
• Report Number: 9710154-2020-00023
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Other Health Care Professional
• 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: 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: 56 YR