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 Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/09/2021

Event Type  Injury  

Event Description

Hit a vein during the last synvisc-one injection [venous injury].Injection against pain [pain].Had synovitis [synovitis].Case narrative: initial information received on (b)(6) 2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a 62 years old male patient who reported hit a vein during the last synvisc-one injection and injection against pain 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.At the time of the event, the patient had ongoing osteoarthritis.On (b)(6) 2021, the patient received synvisc one injection at a dose of 6 ml once (lot, batch number, expiry date, strength, route - unknown) for osteoarthritis.Information on batch number was requested.On an unknown date after an unknown latency patient had (synovitis).After an unknown latency in 2021 doctor gave him an injection against (pain) next day.After a latency of same day on (b)(6) 2021 the doctor hit a vein during the last synvisc-one injection (venous injury) (medically significant).Action taken: not applicable.An unknown corrective treatment of bandage was received for the event (hit a vein during the last synvisc-one injection).It was not reported if the patient received a corrective treatment for the event (injection against pain, had synovitis).Outcome: recovering/resolving for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2022: this case involves a 62 years old male patient who reported hit a vein during the last synvisc-one injection with the use of medical device 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

Hit a vein during the last synvisc-one injection [venous injury] had synovitis [synovitis] ([pain]) case narrative: initial information received on 09-nov-2022 from canada regarding an unsolicited valid serious case received from a consumer/non-hcp.This case is linked to (b)(4) (duplicate) this case involves a 62 years old male patient who reported hit a vein during the last synvisc-one injection 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.At the time of the event, the patient had ongoing osteoarthritis.On (b)(6) 2021, the patient received synvisc one injection at a dose of 6 ml once (lot, batch number, expiry date, strength, route - unknown) for osteoarthritis.There will be no information available on batch number of this case as box had been discarded on an unknown date after an unknown latency patient had (synovitis).After an unknown latency in 2021 doctor gave him an injection against (pain) next day.After a latency of same day on (b)(6) 2021 the doctor hit a vein during the last synvisc-one injection (venous injury) (medically significant).Action taken: not applicable for all events an unknown corrective treatment of bandage was received for the event (hit a vein during the last synvisc-one injection).It was not reported if the patient received a corrective treatment for the event (injection against pain, had synovitis).Outcome: recovering/resolving for all the events a product technical complaint (ptc) was initiated, and the results were pending for the same.Upon internal review on 10-jun-2023, case (b)(4) (to 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 the case (b)(4).Case (b)(4) received with clock start date of 09-nov-2022 would be deleted.Also, country of incidence in this case ((b)(4)) has been updated from unites states to canada.

Manufacturer Narrative

Sanofi company comment dated 15-nov-2022: this case involves a 62 years old male patient who reported hit a vein during the last synvisc-one injection with the use of medical device 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, post injection routine, injection technique and other risk factors would aid in better case assessment.

• 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: 15808554
• MDR Text Key: 303796004
• Report Number: 2246315-2022-00138
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• 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
• 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