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

Lot Number 6RSL050

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

Patient Problems Bronchitis (1752); No Code Available (3191)

Event Date 04/11/2018

Event Type  Injury  

Event Description

Chronic bronchitis.Lacerated bladder.Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a patient via health authorities of united states under reference (b)(4).This case involves an adult patient (gender: unknown) who experienced chronic bronchitis and lacerated bladder, while he/she was treated 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.Concomitant medications included denosumab (prolia).On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate once via intra-articular route ((b)(4), expiration date: (b)(6) 2019) (dose and indication: unknown).On (b)(6) 2018, after an unknown latency, patient was in the hospital for chronic bronchitis (bronchitis chronic) and lacerated bladder (bladder injury).The patient was hospitalized for the events.Action taken: not applicable it was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for chronic bronchitis and as unknown for lacerated bladder.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc one; batch number: (b)(4); global ptc number: (b)(4).The production and quality control documentation for lot number (b)(4) expiration date (2019-10) 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 (b)(4) no capa (corrective and preventive action) is required.(b)(4) continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.As of (b)(6) 2021 there are 9 complaints on file for lot number (b)(4): (1) detached leur-lok hub, (5) adverse event reports, (1) loose luer-lok hub (2 syringes), (1) leaky syringe and (1) broken luer-lok hub.(b)(4) will continue to monitor complaints as stated in sop (b)(4)"product event handling" to determine if a capa is required.Final investigation was completed on (b)(6) 2021.Follow-up was received on (b)(6) 2021 from other healthcare professional.Global ptc number added.No significant information was received.Additional information was received on (b)(6) 2021 from other healthcare professional.Gptc results were received and added.Text was amended accordingly.

• 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: 11235425
• MDR Text Key: 231599746
• Report Number: 2246315-2021-00036
• 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: health professional
• Type of Report: Initial
• Report Date: 01/27/2021

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: No Information
• Device Expiration Date: 10/31/2019
• Device Lot Number: 6RSL050
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention