MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC; INTRA-ARTICULAR HYALURONIC ACID

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

This unsolicited device case from united states was rec'd on (b)(6) 2014 from a physician.This case concerns a pt (demographics not provided) who was hospitalized while receiving treatment with synvisc injection.No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported.On an unk date, pt started treatment with synvisc injection, (route, dosage regimen, batch/lot number and expiration date: not provided) into unspecified location for an unk indication.It was reported that the pt was hospitalized on an unk date during the time between the shots were given and therefore could not get the third injection.It was reported the pt was unable to continue the treatment.Action taken: stopped temporarily.Corrective treatment: not reported.Outcome: unk.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.

Manufacturer Narrative

Pharmacovigilance comment: sanofi company comment dated (b)(4) 2014: this case concerns a pt who was hospitalized (unspecified) after receiving synvisc for unk indication.Although the role of device cannot be ruled out based on the device event temporal relationship; however, lack of detailed info about medical history, lab data, any concurrent medical illnesses, clinical course etc.Of the pt precludes a comprehensive assessment in this case.

• Brand Name: SYNVISC
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: michael murphy ; 55 corporate drive; mail stop: 55d-205a; bridgewater, NJ 08807 ; 9089813633
• MDR Report Key: 3848481
• MDR Text Key: 4614871
• Report Number: 2246315-2014-62892
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PREV MEDS =UNK; CON MEDS =UNK
• Patient Outcome(s): Hospitalization