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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 Problem Device Contamination With Biological Material (2908)
Patient Problems Pain (1994); Skin Discoloration (2074); Swelling (2091); Discomfort (2330); Arthralgia (2355); Joint Swelling (2356); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 12/04/2017
Event Type  malfunction  
Event Description
This unsolicited case from united states was received on 05-feb-2018 from the patient. This case concerns a female patient with unspecified age who received treatment with synvisc one injection and the same day the patient experienced swollen/ swelling that was really bad/swollen/swelling was not in the joint but above and around my joint and pain/ excruciating pain/pain that was really bad/bent over in pain; after few days patient was not able to use my leg and had discoloration of the knee; also, device malfunction was identified for the reported lot number. No relevant medical history and concurrent condition was reported. Patient had received synvisc previously 4 times without issue. Patient was immune-compromised. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection (dose, frequency and expiration date: not reported; lot number: 7rsl021) in the right knee. Within 24 hours, patient had swelling and pain. About 24-36 hours after patient received the injection, patient had swelling and pain that was really bad. Patient was bent over in pain and was not able to use the leg. Patient was in excruciating pain. Patient had discoloration of the knee (latency: few days). It was still swollen and still had pain. The swelling was not in the joint but above and around the joint. There was no fluid in the joint to aspirate with no infection and fever. Patient had lot of other health issues. Further reported, that over the course of weeks, patient was still recovering from it. Action taken: unknown corrective treatment: not reported for all outcome: recovering for swollen/swelling that was really bad/swollen/swelling was not in the joint but above and around my joint and pain/excruciating pain/pain that was really bad/bent over in pain; unknown for not able to use my leg and discoloration of my knee a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same. 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. Seriousness criterion: important medical event of device malfunction.
 
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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
9089817289
MDR Report Key7279835
MDR Text Key100658543
Report Number2246315-2018-00317
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/05/2018
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: 02/19/2018 Patient Sequence Number: 1
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