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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 UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/01/2021
Event Type  Injury  
Event Description
It was infected after taking potential counterfeit of synvisc one [joint infection]. ([swelling of l knee], [arthralgia aggravated]). Not having been able to work [impaired work ability]. Case narrative: initial information received on 13-aug-2021 regarding an unsolicited valid serious case received from a pharmacist from (b)(6). This case involves an unknown age female patient whose knee was infected after taking hylan g-f 20, sodium hyaluronate [synvisc one] and she had not been able to work. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection liquid (solution) once (strength: 48 mg/ 6 ml) (lot, dose, route, indication: unknown) in left knee. On (b)(6) 2021 after a latency of 6 days patient's left injected knee got all swollen and painful (arthralgia and joint swelling; seriousness: hospitalization, intervention required and medically significant). Patient fortunate to have been able to see orthopaedic surgeon who put her on tremadol slow release as well as oxycodone hydrochloride (endone) pain tablets which eased the pain for 8 days. On (b)(6) 2021 patient checked into hospital emergency department because the pain had got so unbearable and blood tests were done. The patient was admitted to the hospital on (b)(6) 2021 where patient had surgery to the knee (arthroscopic wash out) as it was infected (arthritis infective; onset: (b)(6) 2021; latency: few days; seriousness: hospitalization, intervention required and medically significant). This left the patient with so much pain and loss of income from not having been able to work (impaired work ability; onset: 2021; latency: few days; seriousness: disability). Patient would return the unused hylan g-f 20, sodium hyaluronate and would like to claim money back from the pharmacy for the one that had been used. The patient believe it was a bad batch which caused so much pain with time spent in hospital. Action taken: not applicable for both events. The patient was treated with tramadol, oxycodone hydrochloride (endone) and had an arthroscopic washout for the arthralgia associated with arthritis infective; treatment not reported for impaired work ability. At time of reporting, the outcome was unknown for the event it was infected and not having been able to work. Product technical complaint (ptc) was initiated with global ptc number 100149428 on 13-aug-2021 for product. Batch number; unknown; sample status: requested & awaited the investigation was in process.
 
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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 Key12347234
MDR Text Key267421934
Report Number2246315-2021-00139
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,health professional
Type of Report Initial,Followup
Report Date 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
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: 08/20/2021 Patient Sequence Number: 1
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