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

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.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• 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: 12697831
• MDR Text Key: 278371208
• Report Number: 2246315-2021-00167
• 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,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 Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 9RSL014
• 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