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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ Back to Search Results
Lot Number 7RSP010E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Arthralgia (2355); Loss of consciousness (2418); Sweating (2444); No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Event Description
Allergic reaction to shots [allergic reaction], sweated through my pj's and bedding [sweating], came home and passed out [passed out], was not able to focus [attention concentration difficulty], didn't feel right [feeling abnormal], crystals in the lungs [lung disorder], times i could barely breath/my breathing thing got worse [difficulty breathing]. Case narrative: initial information received on 04-jun-2018 regarding an unsolicited valid serious case from united states received from a health professional. This case involves an unknown age female patient who experienced allergic reaction to shots, sweated thru my pj's and bedding, came home and passed out, was not able to focus, didn't feel right, crystals in the lungs and times i could barely breath/my breathing thing got worse after she received hylan g-f 20, sodium hyaluronate (synvisc) injection. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2018, the patient received first round of intra-articular synvisc injection, on a unknown dose and frequency for an unknown indication. After the first round, patient came home and passed out and for four days she sweated through her pj's and bedding. Her husband had to get her up to go to bathroom. On an unknown date in 2018, the patient received second round of intra-articular synvisc on an unknown dose (lot number: 7rsp010e; expiration date: 30-jun-2018). After second round it happened again and both times patient could barely breathe. Reportedly, patient passed out after the second time her breathing thing got worse. The patient contacted doctor and he told it was just the flu and that she should go to an urgent care and they would run a test to confirm it was the flu. It was reported that the patient was not able to focus and didn't feel right. She went by her primary and i was told it didn't look good and should to go to the er. After extensive testing they determined she had an allergic reaction to the shots and had developed crystals in my lungs following which she was admitted and stayed in the hospital. It was also reported that the orto. Doctor never contacted her. Action taken: unknown. Corrective treatment: not reported for all events. Outcome: unknown for all events. Seriousness criteria: hospitalization and disability for all events. A product technical complaint was initiated on 20-jun-2018 for synvisc batch lot number 7rsp010 global ptc number (b)(4). The production and quality control documentation for lot 7rsp010 expiration date (2020-06-30) was reviewed. The investigation showed that the product met specifications. No associated non-conformances were noted. Based on the lot batch record review & lot frequency analysis for lot 7rsp010 no capa was required. Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals. This review had not indicated any safety issue. As of 20-jun-18 there were 10 complaints on file for lot 7rsp010 and all related sublots. 4 complaints were on file for lot 7rsp010b: (3) adverse event reports and (1) detached plunger rod. 6 complaints were on file for lot 7rsp010e: (2) adverse event reports, (2) leakage (luer lok hub), (1) barrel finger flange breakage and (1) loose luer lok hub. Sanofi would continue to monitor complaints to determine if a capa was required. Additional information was received on 20-jun-2018. Global ptc number and ptc results were added. Text was amended accordingly.
 
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Brand NameSYNVISC
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key8398805
MDR Text Key138105633
Report Number2246315-2018-00874
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2018
Device Lot Number7RSP010E
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
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: 03/07/2019 Patient Sequence Number: 1
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