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

Lot Number UNKNOWN

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

Patient Problems Inflammation (1932); Pain (1994); Synovitis (2094); Arthralgia (2355); Vascular Dissection (3160)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 01-nov-2022: this case involves an unknown age male patient whose doctor tried to inject right knee in the time, he hit patient's vein while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.

Event Description

Doctor tried to inject right knee in the time, he hit patients vein [venous injury] inflamed synovitis in right knee [synovitis of knee] ([aching (r) knee]) case narrative: initial information received on (b)(6) 2022 from canada regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves an unknown age male patient who reported that doctor tried to inject right knee in the time, he hit patient's vein and inflamed synovitis in right knee with the use of medical device 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.In 2021, the patient received synvisc one injection in his right knee via intra-articular route (with an unknown batch number, expiry date, strength, dose, frequency) for product used for unknown indication.Information regarding batch number cannot be requested.Reportedly, the patient had received 3 shots so far, the first 2 injections were good and nothing went wrong.On an unknown date in 2021, on same day (latency) while receiving injection, when the doctor tried to inject his right knee in the time, he hit his vein (venous injury) (medically significant).The patient had severe pain after his last injection (arthralgia, onset and latency: unknown) and the doctor diagnosed it as an inflamed synovitis in his right knee (synovitis; onset and latency: unknown).Now it had been almost a year and it seemed the effect was wearing off.That can exclude him from another shot in future.Action taken: not applicable for all the events.Corrective treatment: not reported for the events.Outcome was unknown for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

(b)(4) company comment dated 01-nov-2022: this case involves an unknown age male patient whose doctor tried to inject right knee in the time, he hit patient's vein while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.

Event Description

Doctor tried to inject right knee in the time, he hit patients vein [venous injury] inflamed synovitis in right knee [synovitis of knee] ([aching (r) knee]).Case narrative: initial information received on 26-oct-2022 from canada regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves an unknown age male patient who reported that doctor tried to inject right knee in the time, he hit patient's vein and inflamed synovitis in right knee with the use of medical device 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.In 2021, the patient received synvisc one injection in his right knee via intra-articular route (with an unknown batch number, expiry date, strength, dose, frequency) for product used for unknown indication.Information regarding batch number cannot be requested.Reportedly, the patient had received 3 shots so far, the first 2 injections were good and nothing went wrong.On an unknown date in 2021, on same day (latency) while receiving injection, when the doctor tried to inject his right knee in the time, he hit his vein (venous injury) (medically significant).The patient had severe pain after his last injection (arthralgia, onset and latency: unknown) and the doctor diagnosed it as an inflamed synovitis in his right knee (synovitis; onset and latency: unknown).Now it had been almost a year and it seemed the effect was wearing off.That can exclude him from another shot in future.Action taken: not applicable for all the events.Corrective treatment: not reported for the events.Outcome was unknown for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.Upon internal review on 07-nov-2022 case (b)(4) be deleted) was identified to be duplicate of (b)(4) (to be retained).Hence, all the information from the case (b)(4) (to be deleted) has been merged in case id (b)(4).

• Brand Name: SYNVISC ONE
• 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: 15725180
• MDR Text Key: 303045460
• Report Number: 2246315-2022-00134
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male