MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC HYLAN G-F 20; ACID, HYALURONIC, INTRAARTICULAR

Model Number 00089149-02

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Muscle Spasm(s) (1966); Rash (2033); Twitching (2172); Cramp(s) (2193); Numbness (2415); Blood Loss (2597); Convulsion/Seizure (4406)

Event Date 05/12/2001

Event Type  Injury  

Event Description

In 10 second after 2nd year 2nd injection muscle cramps and twitching in right calf of right knee of injection 10 minutes of bleedings (b)(6) 2001 hospitalization.Still 5 months later full body cramping and spasms, loss of some body function numbness in both legs.Neuro check and ¿wm spams¿ body contractions.Conscious/seizure like movement.At this time hospitalization twice.Dr.Made note of rash on right hip of right leg of right knee of injection in (b)(6) and (b)(6) 2001.Rash and bruises amd min¿s spasms, convulsions.

• Brand Name: SYNVISC HYLAN G-F 20
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10816314
• MDR Text Key: 216175422
• Report Number: MW5097746
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 11/01/2001

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/11/2002
• Device Model Number: 00089149-02
• Device Catalogue Number: 8008US-01
• Device Lot Number: 0008914901 L0022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 77