MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A. HYALGAN; INTRA-ARTICULAR INJECTION

Device Problem Partial Blockage (1065)

Patient Problems Headache (1880); Nausea (1970); Dizziness (2194); Joint Disorder (2373); Reaction, Injection Site (2442); Sweating (2444)

Event Date 05/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).No batch number was received on this complaint; therefore, no investigation can be conducted.The case was received from (b)(4).The events " headache, nausea, stent malfunction" have been classified as "serious" since the patient was hospitalized.The events "sweating, light headedness, injection site joint pain, joint tightness" have been classified as non-serious since no seriousness criteria are met.Therefore the case has been classified as serious/unexpected.The relationship between the events " headache, nausea, stent malfunction, sweating, light headedness" and the administration of hyalgan is deemed as being "possible", except for "injection site joint pain and joint tightness" that is deemed as "probable".

Event Description

This spontaneous, serious adverse event was reported by a (b)(6) year-old female patient.On (b)(6)-2016 the patient began hyalgan, 1 injection weekly for osteoarthritis in bilateral knees.Following the patient's first injection she experienced headache and nausea.On an unknown date in (b)(6)2016 the patient was admitted to the hospital and was told that her headache and nausea were due to a 30% blockage of her stent.The patient subsequently missed her second hyalgan injection due to her hospitalization.On an unknown date the nausea and headache resolved.On (b)(6)-2016 the patient received her second hyalgan injection, and the provider used numbing medication prior to injection.After the numbing medication wore off the patient experienced sweating, light headedness, knee pain and knee tightness.The lot number and expiration date were unknown.As of (b)(6)-2016 the patient continued on hyalgan and the outcome of nausea, headache, late administration, sweating, light headedness, knee pain, and knee tightness was resolved.The outcome of stent blockage was unknown.

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 (b)(4), as a consequence, fidia farmaceutici s.P.A.(the manufacturer) is submitting this report even on behalf of (b)(4) (the importer).The present mdr report satisfies the reporting obligations for both companies.No batch number was received on this complaint; therefore, no investigation can be conducted.The case was received from (b)(4) (the fidia's partner in usa).The events " headache, nausea, stent malfunction" have been classified as "serious" since the patient was hospitalized.The events "sweating, light headedness, injection site joint pain, joint tightness" have been classified as non-serious since no seriousness criteria are met.Therefore the case has been classified as serious/unexpected.The relationship between the events " headache, nausea, stent malfunction, sweating, light headedness" and the administration of hyalgan is deemed as being "possible", except for "injection site joint pain and joint tightness" that is deemed as "probable".Follow-up ((b)(6) 2016): this case was downgraded to a non-serious case because the follow-up information confirmed the serious adverse reactions which led the hospitalization were not attributable to hyalgan.

Event Description

This spontaneous, serious adverse event was reported by a (b)(6)-old female patient.On (b)(6) 2016 the patient began hyalgan, 1 injection weekly for osteoarthritis in bilateral knees.Following the patient's first injection she experienced headache and nausea.On an unknown date in (b)(6) 2016 the patient was admitted to the hospital and was told that her headache and nausea were due to a 30% blockage of her stent.The patient subsequently missed her second hyalgan injection due to her hospitalization.On an unknown date the nausea and headache resolved.On (b)(6) 2016 the patient received her second hyalgan injection, and the provider used numbing medication prior to injection.After the numbing medication wore off the patient experienced sweating, light headedness, knee pain and knee tightness.The lot number and expiration date were unknown.As of (b)(6) 2016 the patient continued on hyalgan and the outcome of nausea, headache, late administration, sweating, light headedness, knee pain, and knee tightness was resolved.The outcome of stent blockage was unknown.Follow-up ((b)(6) 2016): patient reported that she received 2 hyalgan injections and is scheduled to get her third on (b)(6) 2016.The headache, nausea, sweating, and light headedness resolved and she does not attribute these to hyalgan.The patient does not attribute her stent blockage and hospitalization to hyalgan.The knee tightness resolved but the pain is ongoing though better than prior to hyalgan treatment.So, this case was downgraded to a non-serious case.

• Brand Name: HYALGAN
• Type of Device: INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031
• Manufacturer (Section G): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031
• Manufacturer Contact: giuseppe di sante ; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031 ; 0498232827
• MDR Report Key: 5706197
• MDR Text Key: 46801970
• Report Number: 9610200-2016-00005
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2016,06/30/2016

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2016
• Distributor Facility Aware Date: 06/03/2016
• Date Report to Manufacturer: 06/08/2016
• Initial Date Manufacturer Received: 05/17/2016
• Initial Date FDA Received: 06/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR