MAUDE Adverse Event Report: GEL FOAM

Device Problem Insufficient Information (3190)

Patient Problems Nerve Damage (1979); Pain (1994); Complaint, Ill-Defined (2331); Arachnoiditis, Spinal (2390)

Event Date 01/01/1999

Event Type  Injury  

Event Description

I was recently diagnosed with "arachnoiditis".My orthopedic surgeon used "gel foam" during the surgery which caused permanent nerve damage and chronic pain in my spine since having surgery in 1999.I am unable to perform everyday duties in my life.

• Brand Name: GEL FOAM
• Type of Device: GEL FOAM
• MDR Report Key: 5053995
• MDR Text Key: 24998847
• Report Number: MW5055917
• Device Sequence Number: 0
• Product Code: FQL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 39 YR
• Patient Weight: 93