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

Lot Number 16520-1

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

Patient Problems Erythema (1840); Herpes (1898); Itching Sensation (1943); Necrosis (1971); Pain (1994); Rash (2033); Skin Discoloration (2074); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of necrosis at the injection site was considered unexpected and possibly related to the treatment.The serious event of possible (b)(6) was considered unexpected and unrelated to the treatment.Serious criteria include the need for multiple medical interventions including hospitalization, antiviral and antibiotic medications, nitropatch and debridement of the foot.The non-serious, unexpected events of erythema and pruritus at the injection site, and rash, pain in extremity, peripheral swelling and skin discoloration of the leg and foot were considered possibly related to the treatment.Potential contributory factors include injection technique, (b)(6) reactivation and vasculopathy, although peripheral artery vasculopathy secondary to (b)(6) is a rare event.Risk factors for (b)(6) infection include age in the 7th decade of life.The case meets the criteria for expedited reporting to the regulatory authorities.Manufacturer narrative: lot number was not reported.However, the expiry date was reported as 31-aug-2021, which suggests that the lot number was 16520-1 since it is the only durolane batch with this expiry date.Brr was performed on lot 16520-1.No potential quality issues have been identified in the manufacturing process of the specified batch.The batch is manufactured and released according to (b)(4) quality management system.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.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 07-jun-2019 by the national competent authority which refers to a male aged (b)(6).The patient's medical history included osteoarthritis bilateral knees, mild hearing impairment, ulnar nerve compartment release surgery, and dyslipidemia.Concomitant treatments included celecoxib [celecoxib], tylenol arthritis [tylenol arthritis], rosuvastatin [rosuvastatin] - all ongoing for over 1 year.On (b)(6) 2019, the patient received treatment with unknown amount of durolane (lot unknown) to the left knee joint with unknown needle and unknown technique.2 days later, on (b)(6) 2019, injection site started feeling itchy(injection site pruritus).Progressed over next few weeks - initially erythema(injection site erythema) and severe swelling(peripheral swelling) to left lower leg and foot, then it became deep purple(skin discolouration).The patient presented to emergency department on (b)(6) 2019 with severe pain(pain in extremity) and swelling.Seen by orthopedic surgeon who did injection - felt to be necrosis(injection site necrosis) of skin secondary to hyaluronic acid coming out of joint.Patient was seen by both vascular surgeon and dermatologist who agreed with diagnosis.Also potentially atypical presentation of shingles ((b)(6)).Patient was started on pentoxifylline [pentoxifylline] 400 mg po bid and acyclovir [aciclovir] 800 mg po tid (finished 7 day course, potentially to treat suspected shingles) as per dermatology on (b)(6) 2019.On (b)(6) 2019, pentoxifylline increased to 400 mg po tid.On (b)(6) 2019, started applying nitroglycerin patch [glyceryl trinitrate] 0.2 mg/hr to foot.Pain and rash/lesions(rash) on leg were stable after admission.On (b)(6) 2019, physician charted that some lesions on mid shin were lighter in colour, some had dried but the lesions lower on the foot were still deep purple and the location of the pain.Patient reported some improvement in pain after the pentoxifylline was increased on (b)(6) 2019, and improved again after the nitroglycerin patch was added on (b)(6) 2019.Condition continued to improve from (b)(6) 2019 when the foot was debrided.On (b)(6) 2019, the patient's condition had improved drastically - foot was much closer to normal in colour and patient was able to ambulate without significant pain.Patient discharged on (b)(6) 2019 with plans to follow up as an outpatient with a dermatologist.The patient was hospitalized between (b)(6) 2019.The case was assessed as serious by the reporter due to the hospitalization and the interventions required.Outcome at the time of the report: necrosis was recovering/resolving.Erythema was recovering/resolving.Itchy was recovering/resolving.Severe swelling was recovering/resolving.Severe pain was recovering/resolving.Became deep purple was recovering/resolving.Rash/lesions was recovering/resolving.Potentially atypical presentation of shingles was recovering/resolving.

• Brand Name: DUROLANE
• 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: 8734560
• MDR Text Key: 149212001
• Report Number: 9710154-2019-00044
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P170007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 06/25/2019

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: No Information
• Device Expiration Date: 08/31/2021
• Device Lot Number: 16520-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/26/2019
• 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: Initial
• Patient Sequence Number: 1
• Treatment: CELECOXIB; ROSUVASTATIN; TYLENOL ARTHRITIS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR