MAUDE Adverse Event Report: GALDERMA Q-MED UNSPECIFIED HA FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Cyst(s) (1800); Purulent Discharge (1812); Erythema (1840); Inflammation (1932); Pain (1994); Swelling (2091); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the suspect product was reported as an unspecified hyaluronic acid filler; however, we cannot exclude that one of our hyaluronic acid filler products have been used.The serious event of bacterial infection and the non-serious events of erythema, nodule, inflammation, swelling, pain, induration and purulent discharge at implant site and chronic sinusitis were considered expected and possibly related to the treatment.The non-serious events of dental cyst and chronic sinusitis were considered unexpected and unrelated.Potential contributory factors include injection technique, dental cyst and chronic odontogenic sinusitis.Serious criteria include the need for multiple medical interventions.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: 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.Manufacturer narrative: lot number was not reported.Exemption: (b)(4).

Event Description

Case reference number (b)(4) is a literature report received on 04-jun-2019.Netsvyetayeva et al.The impact of lifestyle upon the probability of late bacterial infection after soft-tissue filler augmentation.Infection and drug resistance.2019:12; 855-863.Netsvyetayeva et al.Treatment of late bacterial infections resulting from soft-tissue filler injections.Infection and drug resistance.2019:12; 469-480.A (b)(6) female patient received treatment with total 1 ml of unspecified ha filler to nasolabial folds.On an unknown date, two months later treatment, the patient developed late bacterial infection/biofilm formation with inflammatory swelling, nodules, redness, pain, induration, and the discharge of pus at all treated areas.The diameter of the lesion was reported as less than or equal to 2 cm.On an unknown date, the patient received first therapeutic treatment with ciprofloxacin 500 mg twice a day, clarithromycin 500 mg twice a day, trilac capsules thrice per day orally and hyaluronidase 135 units.The initial treatment was unsuccessful.The patient was then treated for the adverse events in accordance with the m and n scheme which involved the following procedure.Puncturing the lesion with an 18 g needle, followed by drainage of pus and fermented cross-linked ha twice a week, until complete resolution.An allergy test was performed before the first administration of hyaluronidase.It entails subcutaneous injection of 20 units of hyaluronidase into the forearm skin, followed by a 30-minute observation period.At least 72 hours was passed before assessed the result to ensure that any negative results are valid, as intolerance may be either the early or late type.Local administration of hyaluronidase 135 units directly onto the lesion twice a week for 21 days.Oral administration of combination antibiotic therapy included 400 mg moxifloxacin twice per day, 500 mg clarithromycin twice per day.Probiotic formulation consisting of 1.6 billion cfu of lyophilized strains of lactobacillus acidophilus, l.Delbrueckii subsp.Bulgaricus, and bifidobacterium lactis, three capsules per day during the antibiotic therapy and for 1 month after its completion.On an unknown date, the patient received cross-linked ha after resolution of symptoms with the m and n scheme, and remission was observed during the following 2 months.It was informed that patient had four symptom relapsed at same area after each ha administration, despite having been comprehensively treated with the m and n scheme three times.The scheme was successful only after the patient had a tooth with a periodontal cyst extracted and was treated for both infected chronic odontogenic sinusitis at mandibular area.

• Brand Name: UNSPECIFIED HA 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: amy poteate ; 14501 north freeway; fort worth, TX 76177 ; 8175615353
• MDR Report Key: 8741002
• MDR Text Key: 149406612
• Report Number: 9710154-2019-00057
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P040024
• 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: 06/27/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR