MAUDE Adverse Event Report: Q-MED AB DUROLANE; HYALURONIC ACID

Model Number 1082020

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

Patient Problems Pain (1994); Rash (2033); Burning Sensation (2146)

Event Date 10/01/2020

Event Type  Injury  

Event Description

A (b)(6)-year-old woman presented to the emergency room with a three-day history of a progressively worsening, burning, painful rash on her right foot.Twelve hours prior to the onset of her rash, she had received a high concentration hyaluronic acid (ha) injection (durolane) in her right ankle for long-standing osteoarthritis, for which she had previously tolerated low concentration ha.Her examination was notable for non-palpable, nonblanching, broken-net retiform purpura, extending from the plantar aspect of her right foot to her ankle.She was diagnosed with iatrogenic lr, secondary to vessel occlusion from ha.Laboratory workup (blood count, sedimentation rate, prothrombin time, and partial thromboplastin time) was unremarkable.Ankle-brachial index was within normal limits.Upon admission, she was placed on a heparin drip with noted improvement.Heparin was continued throughout her hospitalization for a total of three days.At discharge, she was started on enoxaparin 60mg daily for 14 days and 300mg pentoxifylline three times daily to prevent necrosis.She continued to improve on this therapy for two months, at which time she was transitioned to aspirin 81mg daily.At three months of follow-up, the livedo pattern had improved.She continues on low-dose 81mg aspirin daily.

• Brand Name: DUROLANE
• Type of Device: HYALURONIC ACID
• Manufacturer (Section D): Q-MED AB; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• MDR Report Key: 11823982
• MDR Text Key: 250608127
• Report Number: 3009595577-2021-00001
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2021,04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1082020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR