MAUDE Adverse Event Report: GENZYME COPORATION SYNVISC PFS; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Use of Device Problem (1670)

Patient Problems Renal Failure (2041); Urinary Tract Infection (2120); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Pt reported surgery for bowel obstruction, and had a uti.She was given vancomycin which caused acute kidney failure and put her back in the hosp requiring dialysis for a short.She states everything seems to be getting better now.

• Brand Name: SYNVISC PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME COPORATION
• MDR Report Key: 17020031
• MDR Text Key: 316221313
• Report Number: MW5117958
• 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: Unknown
• Type of Report: Initial
• Report Date: 05/25/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2023
• Patient Sequence Number: 1
• Treatment: VANCOMYCIN
• Patient Outcome(s): Hospitalization
• Patient Sex: Female