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

Lot Number 7F553A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthralgia (2355); Joint Disorder (2373); Reaction, Injection Site (2442)

Event Date 12/01/2017

Event Type  Injury  

Event Description

This case is cross referred with the case (b)(4) (cluster).This unsolicited case from united states was received on 07-dec-2017 from an other non- health care professional.This case concerns a (b)(6) years old patient (gender: not provided) who received treatment with synvisc one injection and after few days had red knee, hot knee, knee pain and knee aspiration.No medical history, past drug, concomitant medication and concurrent condition was provided.On (b)(6) 2017, patient received treatment with intraarticular synvisc one bilateral injection, at a dose of 6 ml once (batch/lot number: 7f553a and expiration date: 07-dec-2018) for bilateral knee pain.It was reported that only one knee received the held product.Patient came on (b)(6) 2017 with the knee injected with the held product red, hot and pain rated as a 10, on a scale of 1-10, 10 being excruciating (onset date: (b)(6) 2017 and latency: few days).The patient also had knee effusion on an unknown date in (b)(6) 2017.Patient was treated by aspiration and steroid.Corrective treatment: aspiration and steroid for all events outcome: unknown for all events a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: required intervention for all events.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7156221
• MDR Text Key: 96112382
• Report Number: 2246315-2017-00282
• 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: 12/07/2017

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: Other
• Device Expiration Date: 12/07/2018
• Device Lot Number: 7F553A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/30/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR