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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
Lot Number 9RSL014
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arthralgia (2355)
Event Date 03/03/2020
Event Type  Injury  
Event Description
She was in a lot of pain; as soon as she had the injection it started to hurt [injection site joint pain] , some swelling (right knee) [injection site joint swelling] synvisc one used for indication: spur [drug use for unapproved indication]. Case narrative: initial information received on 18-oct-2021 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one". Patient id: unknown; country: (b)(6). Study title: patient support program involving synvisc one. This case involves a (b)(6) years old female patient who experienced she was in a lot of pain; as soon as she had the injection it started to hurt, some swelling (right knee) and synvisc one used for indication: spur 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. On (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate injection 6 ml dose (lot - 9rsl014) in right knee for a "spur" (growth) (product use in unapproved indication). On (b)(6) 2020, on the same day, the patient was in a lot of pain; as soon as she had the injection it started to hurt (injection site joint pain), some swelling (right knee) (injection site joint swelling). The patient tolerated the pain for approximately five weeks then received a cortisone injection which stopped the pain. This event of injection site joint pain was leading to intervention. Reportedly, the patient did not recall the exact date of the injection but did say it was the only time she had a synvisc injection. Action taken: not applicable. The patient was treated with cortisone for injection site joint pain and not reported for rest of the events. At time of reporting, the outcome was unknown for the event synvisc one used for indication: spur; recovered for rest of the events. Reporter causality: related for all the events. Company causality: not reportable for product use in unapproved indication; reportable for rest both events.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
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 Key12697831
MDR Text Key278371208
Report Number2246315-2021-00167
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 Foreign,Study,Consumer,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot Number9RSL014
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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: 10/26/2021 Patient Sequence Number: 1
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