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

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535); Microbial Contamination of Device (2303)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

Device malfunction [device malfunction].Extreme pain [acute pain].Case narrative: this case is cross-referenced to cases (b)(4) (cluster).Initial information received on 27-jul-2018 regarding an unsolicited valid non-serious case from united states received from a consumer via social media.This case involves a female patient of unknown demographics who experienced extreme pain and device malfunction (latency:unknown), after receiving 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 an unknown date, the patient received intra articular hylan g-f 20, sodium hyaluronate at an unknown dose once, (lot - 7rsl021) for an unknown indication.On an unknown date, the patient developed extreme pain (pain).Final diagnosis was extreme pain and device malfunction.Corrective treatment: not reported.Outcome: unknown for both events.Seriousness criteria: medically significant for device malfunction.A product technical complaint was initiated on 31-aug-2018 for synvisc-one.Batch number: 7rsl021 (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Follow- up was received on 23-aug-2018.No new information received.Additional information received on 31-aug-2018.Investigation summary received and ptc results added.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 7928529
• MDR Text Key: 125148442
• Report Number: 2246315-2018-00523
• Device Sequence Number: 0
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• 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): Other