MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A HYALURONIC ACID (Y2)

Device Problem Insufficient Information (3190)

Patient Problems Necrosis (1971); Pain (1994); Rash (2033)

Event Type  Injury  

Event Description

This is a (b)(6) case report from the worldwide scientific literature monitoring on the active ingredient "hyaluronic acid" ((b)(6).Skin necrosis from intra-articular hyaluronic acid injection.J cutan med surg.(b)(6) 2015.Pii:7750.2014.14081).A (b)(6) man presented with a 1-month history of painful skin eruption developed 48 hours after a bilateral knee injection with intrarticular hyaluronic acid (brand name not specified) for treatment of knee osteoarthritis.On examination, there was a well-demarcated, livedoid (net-like), violaceous patch on the right knee with a dark center and a lighter border.The left knee was normal.A punch biopsy of the skin was performed and showed atrophic epidermis with patchy necrosis.The viable portions of the epidermis revealed reactive keratinocytes admixed with scattered necrotic keratinocytes.In the dermis, there was an amorphous basophilic foreign material consistent with ha present within both the dermal stroma anda medium sized vein with an associated thrombus formin.Hence, the histologic findings were consistent with tissue necrosis due to ia ha injection entering the cutaneous vasculature.The pt was treated conservatively with topical fusidic acid dressings.The lesion resolved in 4 months' time.Author's comment: tissue necrosis is a rare but serious complication of ha ia injections, which are commonly administered for cosmetic purposes and more recently for treatment of mild to moderate knee oa.It is known that facial skin necrosis is a potential complication of intradermal ha cosmetic injection; this case report brings to attention the possibility that the use of ha ia injections in the treatment of oa can result in similar skin necrosis at uncommon anatomic locations corresponding to the site of ha injection.Although tissue necrosis is a rare complication, physicians need to be aware of this possibility and should be mindful of potential treatment options to manage this adverse event.

Manufacturer Narrative

(b)(4).On (b)(6) 2011, the fda granted the permission for the manufacturer fidia farmaceutici s.P.A.To submit a single mdr for adverse events that involve medical devices manufactured by fidia farmaceutici s.P.A.And imported into the usa by fidia pharma usa, inc as a consequence, fidia farmaceutici s.P.A.(the manufacturer) should submit reportable cases on behalf of fidia pharma usa inc (the importer).However, sine this is a non-us case which fidia farmaceutici s.P.A.Has become aware of in its role of product manufacturer, fidia pharma usa does not have any reporting obligation.This is a case-report from (b)(6) originating from the scientific literature monitoring on the active ingredient "hyaluronic acid".It should be noted that the paper does not report any brand name.Fidia farmaceutici no longer sells the product in (b)(6) (the last supply was in (b)(6) 2011), however in the absence of a specified invented name, or any other alternative reasons for exclusion, the ownership of the product suspected to be responsible for the occurrence cannot be ruled out.This is the first case of skin necrosis for hyalgan since 1987 when it was first put on the market.

• Brand Name: HYALURONIC ACID (Y2)
• Type of Device: HYALURONIC ACID
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A; abano terme, (pd)
• Manufacturer Contact: giuseppe di sante, md, safety surv ; via ponte della fabbrica 3/a; abano terme (pd) 35031 ; IT 35031 ; 498232827
• MDR Report Key: 4734263
• MDR Text Key: 5707280
• Report Number: 9610200-2015-00004
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• 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
• Date Manufacturer Received: 03/23/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR