MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A. HYALGAN; HYALURONIC ACID FOR INTRA ARTICULAR USE

Device Problem Insufficient Information (3190)

Patient Problems Gangrene (1873); Tissue Damage (2104); Disability (2371)

Event Type  Injury  

Event Description

This is a spontaneous report from an (b)(6), collected by the local distributor in the territory and passed on to fidia farmaceutici s.P.A.As product manufacturer.A report from a physician (orthopedist) was received by the (b)(6) business partner on (b)(6) 2014.An orthopedist reported by phone that she treated a female patient (details not reported) with hyalart (hyaluronate sodium - a further brand name for hyalgan).The patient developed a gangrene and was admitted to a (b)(6).She had to undergo a leg amputation.The reporting physician mentioned that the hospital expressed the suspicion of a contamination of the respective batch.

Manufacturer Narrative

Exemption number (b)(4).On november 28, 2011, the fda granted the permission for the manufacturer fidia farmaceutici spa to submit a single mdr for adverse events that involve medical devices manufactured by fidia farmaceutici spa and imported into the usa by fidia pharma usa, inc.As a consequence, fidia pharmceutici spa (the manufacturer) should submit reportable cases on behalf of (b)(4) (the importer).However, since this is a non-us case of which fidia farmaceutici s.P.A.Has become aware in its role of product manufacturer, fidia pharma usa does not have any reporting obligation.Fidia farmaceutici spa comments: this case lacks sufficient information (e.G.Patient's demographics, complete details of the event, therapy dates and dosages of hyalgan, complete medical and social history, concomitant medications, laboratory/diagnostic results, etc) to make a complete a medical and causal assessment.Moreover, no batch number was received on this complaint, therefore, no investigation can be conducted at the time being.The product is guaranteed as being absolutely sterile.Before distribution, it must pass each of the scheduled chemical, biological and microbiological tests.Moreover, no external contamination can be suspected if the product was stored and handled according to the package instructions.Moreover, no cluster of septic arthritis, possibly indicating a batch contamination, was received at the present time and in the past months.The occasional reports of septic arthritis after hyalgan injections have never been traced back to a contamination of the product itself, but were probably secondary to the injection procedure, the more likely explanation for the occurrence of the event and the reported outcome.As for any other intra-articular therapies, strict aseptic technique is recommended in administering hyalgan.This is the first case of gangrene associated with hyalgan in over 25-years of post-marketing experience.Additional information has been requested and will be provided as soon as it becomes available.

• Brand Name: HYALGAN
• Type of Device: HYALURONIC ACID FOR INTRA ARTICULAR USE
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A.; abano terme, pd
• Manufacturer Contact: giuseppe di sante, md ; via ponte della fabbrica 3/a; abano terme, (pd) 35031 ; IT 35031 ; 390498232
• MDR Report Key: 3716110
• MDR Text Key: 4246450
• Report Number: 9610200-2014-00003
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2014

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: 03/12/2014
• Initial Date FDA Received: 03/20/2014
• 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): Hospitalization; Required Intervention; Disability