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); Muscle Spasm(s) (1966); Therapeutic Response, Decreased (2271); Arthralgia (2355); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Allergic to product [allergic reaction] ([device ineffective], [aching (r) knee], [joint range of motion decreased], [heaviness in leg], [movements reduced], [spasms], [swelling of r knee]) case narrative: initial information from canada received on 11-dec-2020 regarding an unsolicited valid serious case received from the patient via call center.This case is linked to cases 2020sa358075 and 2020sa358195 (same patient for left knee), 2020sa358080 (same patient for injection #1; right knee), 2020sa358096 (same reporter).This case involves an unknown age female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc) and later was allergic to the product the patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medication included: diuretics.On 26-nov-2020, the patient received hylan g-f 20, sodium hyaluronate (second injection), formulation solution for injection (dose, route, frequency, batch number: unknown) for unknown indication in the right knee.On an unknown date in 2020, after unknown latency, patient experienced soreness and pain (arthralgia), heavy leg (limb discomfort), could not bend her knee (joint range of motion decreased), excessive pain (arthralgia), could not move (mobility decreased), also had spasm (muscle spasm) with no beneficial effect at all (device ineffective).It was reported that her knee was so thick (joint swelling) even after being on diuretics.Patient further reported that her doctor gave her cortisone shot in her knee, but symptoms did not get improved, however, the symptoms got relieved in few days (unknown 2020) later and she could go to work again with limited movement of her knees.Her doctor decided to not give her the 3rd injection because it seemed that she had allergy to the product (hypersensitivity) (onset: 2020 and latency few days).Patient still had the box of the third injection (9rsp017f and expiration date: sep-2022).Action taken: drug withdrawn corrective treatment: cortisone the patient outcome is reported as unknown for hypersensitivity (recovering/resolving for joint range of motion decreased and recovered for other symptoms) a product technical complaint was initiated and the results for the same was pending.

Event Description

Allergic to product [allergic reaction] ([device ineffective], [aching (r) knee], [joint range of motion decreased], [heaviness in leg], [movements reduced], [spasms], [swelling of r knee]).Case narrative: initial information from canada received on 11-dec-2020 regarding an unsolicited valid serious case received from the patient via call center.This case is linked to cases (b)(4) and (b)(4) (same patient for left knee), (b)(4) (same patient for injection #2; right knee), (b)(4) (same reporter).This case involves an unknown age female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc) and later was allergic to the product the patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medication included: diuretics.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate (first injection), solution for injection (dose, route, frequency, batch number: unknown) for unknown indication in the right knee.On an unknown date in 2020, after unknown latency, patient experienced soreness and pain (arthralgia), heavy leg (limb discomfort), could not bend her knee (joint range of motion decreased), excessive pain (arthralgia), could not move (mobility decreased), also had spasm (muscle spasm) with no beneficial effect at all (device ineffective).It was reported that her knee was so thick (joint swelling) even after being on diuretics.Patient further reported that her doctor gave her cortisone shot in her knee, but symptoms did not get improved, however, the symptoms got relieved in few days (unknown 2020) later and she could go to work again with limited movement of her knees.Her doctor decided to not give her the 3rd injection because it seemed that she had allergy to the product (hypersensitivity) (onset: 2020 and latency few days).Patient still had the box of the third injection (lot: 9rsp017f and expiration date: sep-2022).Action taken: unknown.Corrective treatment: cortisone.The patient outcome is reported as unknown for hypersensitivity (recovering/resolving for joint range of motion decreased and recovered for other symptoms).A product technical complaint (ptc) was initiated on 11-dec-2020 for synvisc for unknown batch number and global ptc number: 100088387 the product lot number was not provided; therefore, a batch record review was not possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: 23-dec-2020.Additional information was received on 23-dec-2020 from healthcare professional.Global ptc number and its results were added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11019148
• MDR Text Key: 226335333
• Report Number: 2246315-2020-00171
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention