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

Lot Number 9RSLO16ZC

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Allergic reactions to synvisc-one [allergic reaction].Was in so much pain [knee pain].Could not walk even with a cane [unable to walk].Knee was puffy, swollen [knee swelling].Knee was puffy, swollen, stiff that she could not move it [stiff knees].Case narrative: initial information received on 20-jul-2020 from canada from regarding an unsolicited valid serious case received from a patient.This case involves a (b)(6) years old female patient who experienced allergic reactions to synvisc-one, after she was 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 took hylan g-f 20, sodium hyaluronate, solution for injection, (dosage, route, indication unknown), once in knee, lot number - 9rslo16zc, expiry date: 30-apr-2022.Reportedly, the doctor was away right after the injection.On an unknown date in 2020, after unknown latency, the patient was in so much pain, she could not walk even with a cane and knee was puffy, swollen, stiff that she could not move it.The following week the patient saw the doctor and was told that she had allergic reactions to hylan g-f 20, sodium hyaluronate and she could never have it again.The patient was asking for a refund.Action taken- not applicable for all events.Corrective treatment: not reported.The patient outcome is reported as unknown for allergic reaction to synvisc-one.A product technical complaint was initiated and results were pending for the same.

Event Description

Allergic reactions to synvisc-one [allergic reaction], was in so much pain [knee pain], could not walk even with a cane [unable to walk], knee was puffy, swollen [knee swelling], knee was puffy, swollen, stiff that she could not move it [stiff knees].Case narrative: initial information received on 20-jul-2020 from canada from regarding an unsolicited valid serious case received from a patient.This case involves a 46 years old female patient who experienced allergic reactions to synvisc-one, after she was 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 took hylan g-f 20, sodium hyaluronate, solution for injection, (dosage, route, indication unknown), once in knee, lot number - 9rslo16zc, expiry date: 30-apr-2022.Reportedly, the doctor was away right after the injection.On an unknown date in 2020, after unknown latency, the patient was in so much pain, she could not walk even with a cane and knee was puffy, swollen, stiff that she could not move it.The following week the patient saw the doctor and was told that she had allergic reactions to hylan g-f 20, sodium hyaluronate and she could never have it again (event assessed as serious due to disability).The patient was asking for a refund.Action taken- not applicable for all events.Corrective treatment: not reported.The patient outcome is reported as unknown for allergic reaction to synvisc-one.A product technical complaint (ptc) was initiated on 20-jul-2020 for synvisc one with batch number: 9rsl016zc and global ptc number: (b)(4).The production and quality control documentation for lot number 9rsl016zc expiration date: 30-apr-2020 was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number 9rsl016zc no capa was required.All adverse event reports with or without lot numbers are continuously monitored, 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.As of 27jul2020 there are 2 complaints on file for lot number 9rsl016z and all related sublots.1 complaint is on file for lot number 9rsl016z: (1) air bubble.1 complaint is on file for lot number 9rsl016zc: (1) adverse event report.Complaints will be continuously monitored to determine if a capa was required.Investigation complete date: 28-jul-2020.Additional information was received on 28-jul-2020 from healthcare professional.Global ptc number and its results were added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10326011
• MDR Text Key: 207613007
• Report Number: 2246315-2020-00083
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Lot Number: 9RSLO16ZC
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 46 YR