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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Inadequate Pain Relief (2388); Hyperextension (4523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Removed 9 ml of fluid from her right knee [joint aspiration]. Leg started to hyperextend [limb hyperextension]. Leg started to hyperextend and there was excruciating pain when she straightened it/ feels sharp pain [leg pain] ([pain aggravated]). Hears a bit of creaking [joint crepitation]. Case narrative: initial information received on 23-jul-2021 from (b)(6) regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a (b)(6) years old female patient who experienced removed 9 ml of fluid from her right knee, leg started to hyperextend, leg started to hyperextend and there was excruciating pain when she straightened it/ feels sharp pain and hears a bit of creaking while being treated with 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. At the time of the event, the patient had ongoing arthritis in the knee, polio and thinning of the bone. On (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate injection, dose 6 ml total (with an unknown batch number) for osteoarthritis. On an unknown date, after unknown latency, the patient leg started to hyperextend (joint hyperextension) and there was excruciating pain when she straightened it (pain in extremity). The patient felt a little bit of relief and rested for 2-3 days after but started feeling the same thing later in the week. The pain got progressively worse (pain) and then she heard a bit of creaking (joint noise) and felt sharp pain (pain). The medical doctor removed 9 ml of fluid from her right knee (joint aspiration; intervention required). Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events (leg started to hyperextend, leg started to hyperextend and there was excruciating pain when she straightened it/ feels sharp pain, hears a bit of creaking, removed 9 ml of fluid from her right knee, pain got progressively worse). At time of reporting, the outcome was not recovered / not resolved for all events.
 
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Brand NameSYNVISC ONE
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
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key12257666
MDR Text Key264490798
Report Number2246315-2021-00134
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,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2021
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: 08/02/2021 Patient Sequence Number: 1
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