MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC; INTRA-ARTICULAR HYALURONIC ACID

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling (2091); Alteration In Body Temperature (2682)

Event Date 01/01/2014

Event Type  Injury  

Event Description

This unsolicited device case was received from united states on (b)(4) 2014 from a consumer (patient's husband).This case concerns a pt who had infection in her left shoulder (joint infection) after receiving treatment with synvisc injection in her left shoulder (off-label use).No medical history, past drugs, other concomitant medication or concurrent conditions were reported.On an unk date in 2014, the pt initiated treatment with synvisc injection, at a dose of 02 ml (route, frequency, batch/lot number and expiration date) into her left shoulder (off label use) for arthritis.On (b)(6) 2014, the pt received third injection of synvisc in her left shoulder and completed the treatment for arthritis.Later, the pt started experiencing pain "at a 13" on a 1-10 pain scale in her shoulder with mild arm swelling.The pt described that her arm was crimson in color and that an external temperature indicator read 104 (units not provided) on the temperature reading on the skin of her arm.Also, the pt complained that her left arm was inflamed below the injection site due to which ultrasound and mri were performed but the results for both were unk at the time of report.It was reported that they visited the treating doctor four times and later on (b)(6) 2014, the patient was admitted into the hospital.On an unk date in (b)(6) 2014, the pt underwent one surgery one week later to clear up the infection in her shoulder.Then she had second surgery on her shoulder joint and the cultures were performed which indicated the presence of e.Coli.The pt received two units of blood post her surgeries.The pt had a peripherally inserted central catheter (picc) line and getting an antibiotic (unspecified at the time of report) which put her at the risk for getting c.Difficile.It was reported that the pt could not be discharged due to the ongoing treatment.The reporter was concerned about the batch of synvisc that was used for patient.Action taken: no action taken.Outcome: not recovered/not resolved.A pharmaceutical criteria: hospitalization and surgery for the event of "infection in her left shoulder".

Manufacturer Narrative

Pharmacovigilance comment: sanofi company comment dated (b)(4) 2014: in this case, the causal role of synvisc cannot be excluded for the occurrence of the event of infection in her left shoulder, however, the lack of info regarding the concomitant medications used by the pt, the past medical history of the pt and the concurrent conditions of the pt precludes the complete case assessment.

• Brand Name: SYNVISC
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME CORPORATION; 1125 pleasantview terrace; ridgefield NJ 07657 239
• Manufacturer (Section G): GENZYME CORPORATION; 1125 pleasantview terrace; ridgefield NJ 07657 239
• Manufacturer Contact: 55 corporate drive; bridgewater, NJ 08807 ; 9089816698
• MDR Report Key: 3766655
• MDR Text Key: 4485605
• Report Number: 2246315-2014-45734
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• 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?: No
• Date Manufacturer Received: 04/08/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR