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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Death  
Event Description
Died [death nos]. So sore that last time he had it [pain]. Case narrative: initial information received on 27-jul-2021 from (b)(6) regarding an unsolicited valid serious case received from a patient wife. This case involves an unknown age male patient who experienced died and so sore that last time he had medical device hylan g-f 20, sodium hyaluronate (synvisc). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection, (dosage and route, lot number unknown) for unknown indication. The patient received 3 synvisc injections and it was so sore (pain) that last time he had it and he never had it again. The patient died more than 10 years ago on an unknown date in 2011. This event was aassessed as medically significant and leading to death. It was unknown if an autopsy was done. The cause of death was reported as death nos. Action taken- unknown it was not reported if the patient received a corrective treatment for the events (so sore that last time he had it, died). At time of reporting, the outcome was unknown for the event so sore that last time he had it and was fatal for the event died.
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Type of DeviceMOZ
Manufacturer (Section D)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
bridgewater 08807
MDR Report Key12255075
MDR Text Key264393056
Report Number2246315-2021-00133
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,health profe
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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: 07/30/2021 Patient Sequence Number: 1