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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number UNKNOWN
Device Problem No Apparent Adverse Event (3189)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Type  Injury  
Event Description
Unable to wak [walking difficulty] ([muscle contracture], [pain legs]). Chest infection [chest infection]. Case narrative: initial information received on 04-jun-2018 from (b)(6) regarding an unsolicited valid serious case received from a consumer. This case involves an unknown age female patient who was unable to walk (latency: few days) and developed a chest infection (latency: unknown), after receiving an injection of synvisc-one. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an intra-articular synvisc-one injection, dose 6 ml (indication and batch number: unknown). On an unknown date after receiving the injection, the patient reported that she was unable to walk (latency: few days) and experienced the same for at least one week. After receiving the injection, patient reported that she had an adverse reaction to synvisc-one and reported muscles in both legs from knee down contracted and she ended up in a wheelchair. Further, it was reported that the patient suffered tremendous pain in both legs from end of (b)(6). On an unknown date after receiving the injection, patient developed chest infection (latency: unknown). The patient states that the doctor never said there would be a reaction. She also stated that, she is upset as her trip had to postponed as she developed a chest infection while on the journey. Corrective treatment: wheelchair for unable to walk. Seriousness criterion: disability for unable to walk, medically significant for chest infection. Outcome: unknown both events. A product technical complaint was initiated on 07-jun-2018 for synvisc one, batch number: unknown , global ptc number (b)(4). The product lot number was not provided; therefore, a batch record review is not possible. Based on the lack of information provided, no capa is required. It is the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result is identified and mitigated through the ncr process. Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals. This review has not indicated any safety issue. Sanofi will continue to monitor adverse events to determine if a capa is required. Additional information was received on 07-jun-2018. Ptc results were added. Upon internal review 07-jun-2018 eu/ca form was updated and mir form was attached in the case and.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
MDR Report Key7919587
MDR Text Key122150350
Report Number2246315-2018-00607
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
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
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/28/2018 Patient Sequence Number: 1
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