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

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Has been hurting so bad, it was more painful than what patient was normally experiencing [pain aggravated]. Case narrative: initial information received on (b)(6) 2021, from (b)(6) regarding an unsolicited valid social media serious case received from a consumer/non-hcp. This case involves adult patient who has been hurting so bad, it was more painful than what patient was normally experiencing while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, batch number, route, indication, frequency: unknown). Information for batch number requested. On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had been hurting and was so bad. It was more painful than what patient was normally experiencing (pain) (intervention required) and received cortisone to ease the pain. Action taken: unknown. Corrective treatment: cortisone for pain. At time of reporting, the outcome was unknown for the event has been hurting so bad, it was more painful than what patient was normally experiencing.

• Brand Name: SYNVISC
• Type of Device: MOZ
• 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 Key: 13087476
• MDR Text Key: 285174387
• Report Number: 2246315-2021-00183
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: 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: 12/27/2021 Patient Sequence Number: 1