MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE 48 MG; ACID, HYALURONIC, INTRAARTICULAR

Lot Number BRSL039D

Device Problems Break (1069); Fracture (1260); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  malfunction  

Event Description

Synvisc one, lower portion of glass tube under plastic hand fractured, broke apart and fell onto floor, did not cause puncture wound to provider or patient.Lot number brsl039d, exp date: 09/2024.Fda safety report id # (b)(4).

• Brand Name: SYNVISC ONE 48 MG
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 14575601
• MDR Text Key: 293286517
• Report Number: MW5110040
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 05/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: BRSL039D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American