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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 7RSL021
Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Microbial Contamination of Device (2303)
Patient Problem Pain (1994)
Event Type  malfunction  
Event Description
Device malfunction [device malfunction]. Extreme pain [acute pain]. Case narrative: this case is cross-referenced to cases (b)(4) (cluster). Initial information received on 27-jul-2018 regarding an unsolicited valid non-serious case from united states received from a consumer via social media. This case involves a female patient of unknown demographics who experienced extreme pain and device malfunction (latency:unknown), after receiving hylan g-f 20, sodium hyaluronate (synvisc one). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received intra articular hylan g-f 20, sodium hyaluronate at an unknown dose once, (lot - 7rsl021) for an unknown indication. On an unknown date, the patient developed extreme pain (pain). Final diagnosis was extreme pain and device malfunction. Corrective treatment: not reported. Outcome: unknown for both events. Seriousness criteria: medically significant for device malfunction. A product technical complaint was initiated on 31-aug-2018 for synvisc-one. Batch number: 7rsl021 (b)(4). An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021. The product met all release testing at time of manufacture in june 2017. Retain samples were retested due to the unexpected increase in adverse events. Higher than expected endotoxin results were obtained. In addition, the presence of microbial contamination was also confirmed. The cause of these events was under investigation. Once this investigation is completed, corrective and preventive actions would be implemented. Follow- up was received on 23-aug-2018. No new information received. Additional information received on 31-aug-2018. Investigation summary received and ptc results added. Clinical course updated. Text amended accordingly.
 
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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 Key7928529
MDR Text Key125148442
Report Number2246315-2018-00523
Device Sequence Number0
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 10/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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: 10/02/2018 Patient Sequence Number: 1
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