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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC DISPO IA INJECTION 2ML MOZ

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC DISPO IA INJECTION 2ML MOZ Back to Search Results
Lot Number ARSP001ZB
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Swelling/ Edema (4577)
Event Date 11/26/2021
Event Type  Injury  
Event Description
Swelling. Case narrative: initial information received on 30-nov-2021 regarding an unsolicited valid serious case received from a physician. This case involves a (b)(6) female patient who experienced swelling while being treated with hylan g-f 20, sodium hyaluronate [synvisc dispo ia injection 2ml]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started receiving synvisc dispo ia injection 2ml (dosage unknown, lot number: arsp001zb) (stop date of administration: around (b)(6) 2021). On (b)(6) 2021, swelling developed. On an unknown date, the outcome of swelling was unknown. The patient developed a serious swelling (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of hylan g-f 20 and sodium hyaluronate. This event was leading to intervention. The patient was hospitalized for this event. Action taken with hylan g-f 20, sodium hyaluronate (synvisc dispo ia injection 2ml) was unknown. It was not reported if the patient received a corrective treatment for the event (swelling). At time of reporting, the outcome was unknown for the event swelling. Reporter comment: causality with synvisc dispo ia injection 2ml: probable.
 
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Brand NameSYNVISC DISPO IA INJECTION 2ML
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 Key12957173
MDR Text Key281911834
Report Number2246315-2021-00179
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberARSP001ZB
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/07/2021 Patient Sequence Number: 1
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