MAUDE Adverse Event Report: EPIDURAL NEEDLE; NEEDLE, SPINAL, SHORT TERM

Device Problem Malposition of Device (2616)

Patient Problems Muscle Spasm(s) (1966); Muscle Weakness (1967); Pain (1994); Burning Sensation (2146)

Event Date 05/01/1999

Event Type  Injury  

Event Description

Arachnoiditis; i was given a steroid epidural injection at the age of (b)(6) for minor pain and flexibility issues.She planned to do it without fluoroscopy, and assured me that the risks were little to none.She said the worst that could happen was a spinal headache, but that it would go away in a day or two.During the procedure, she could not find the epidural space, i had several needle marks in that area afterwards.She then punctured my dura, and injected corticosteroids directly into my spinal canal instead of the epidural space that she was aiming for.I had a lightning bolt of terrible pain radiate through my whole body, and i screamed and screamed in pain.It was like a switch was flipped, because after that, i had much more pain than i'd really ever experienced before, and it never, ever, went away.It just got progressively worse as time went on, and doctors have unfortunately not been much help at all.Even though it was because of them that i was there in the first place.I am now (b)(6) years old, and have been in constant, severe pain for all of my adult life.Almost 22 years now.I don't even remember what it feels like to not be in pain, but i really wish i did.Along with the sever constant back pain, have formication on my legs and arms, burning feet, electric shocks of pain, muscle spasms and muscle weakness.Fda safety report id# (b)(4).

• Brand Name: EPIDURAL NEEDLE
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• MDR Report Key: 10903801
• MDR Text Key: 218697525
• Report Number: MW5098104
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/21/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 16 YR
• Patient Weight: 61