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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Headache (1880); Nausea (1970); Shaking/Tremors (2515); Ambulation Difficulties (2544)
Event Date 02/01/2001
Event Type  Injury  
Event Description
In bed for weeks, now walk with a cane [bedridden], shaking [shaking], big red areas [redness], headache [headache] , in bed for weeks, now walk with a cane [walking difficulty] , nausea [nausea], chills [chills], right swelling [swelling of r knee], pain [aching (r) knee], case narrative: deletion cancelled for the case. Initial information was received on 08-jan-2021 regarding an unsolicited valid serious case from a patient via health authorities of united states under reference mw5097745. This case involved an adult patient (gender: unknown) who was in bed for weeks, now walk with a cane (bedridden, gait disturbance), shaking, big red areas, headache, nausea, chills, right swelling and pain, after receiving 3rd injection of medical device hylan g-f 20, sodium hyaluronate (synvisc). The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. The patient was not allergic to eggs (asked before injection). On an unknown date, the patient 1st and 2nd injections of synvisc which were perfect. On an unknown date, the patient received 3rd injection (shot) of synvisc (hylan g-f 20, sodium hyaluronate) injection, liquid (solution) (strength: 16mg/2ml) via intra-articular route (dose, frequency, indication and lot - unknown). Information on batch number was requested. On (b)(6) 2001, after unknown latency of receiving 3rd injection of synvisc, the patient had right knee swelling (joint swelling), big red areas (erythema), headache, nausea, shaking (tremor), pain (arthralgia), chills, in bed for weeks (bedridden), now walk with a cane (gait disturbance). The events- bedridden and gait disturbance were assessed as medically significant and were leading to disability. All other events were assessed as medically significant only. The patient was going to allergist and pain doctor (internist). The patient had nightmare results from the 3rd shot. The patient asked that what have stopped the number of cases, the reported problems. If the patient had been told all of this with by the allergist the patient could never have tried final diagnosis was pain, right swelling, chills, nausea, headache, big red areas, shaking, and in bed for weeks, now walk with a cane. Action taken: not applicable for all the events corrective treatment: cane for gait disturbance; not reported for rest of events the patient outcome is reported as unknown for all the events a product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc. 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 lack of information provided, no capa (corrective and preventive action) was required. It was the requirement to review all finished batch records for specification conformation prior to release. Any out of specification result is identified and mitigated through the ncr (non-conformances report) 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 surveillance effort to detect safety signals. This review did not indicate any safety issue. Sanofi would continue to monitor if a capa is required. Investigation complete date: 27-jul- 2021 with summarized conclusion as no assessment possible follow up information was received on 08-jan-2021 from other healthcare professional. Global ptc number was added. No significant information was received. Additional information was received on 27-jul-2021 from other healthcare professional. Global ptc number and its results were added. Clinical course updated. Text amended accordingly.
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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 Key12255061
MDR Text Key270555946
Report Number2246315-2021-00132
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 health professional
Type of Report Initial
Report Date 07/30/2021
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? No
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