MAUDE Adverse Event Report: IMMOBILIZER

Catalog Number 7704

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Arthritis (1723); Pain (1994); Arthralgia (2355); Ambulation Difficulties (2544)

Event Date 08/09/1996

Event Type  Death  

Event Description

After i got the leg data: ko, immobilizer off, i would get something catching in knee when i bend down, later it started to do more when walking.Just got away from the table to get up, felt my knee turn when getting up to stand, that was with the wrap.After it was time to take off wrap, next day it did it again, with me walking, stop, step down on stair and sidewalk, in front of post office and back up on stair into truck/caravan to go home, the next day same thing happen.Leg ache at night in bed.Sidewalk even it showed.Arthritis leg, leg pain, stiff ankle.(b)(4).

• Brand Name: IMMOBILIZER
• Type of Device: IMMOBILIZER
• MDR Report Key: 5580882
• MDR Text Key: 42871873
• Report Number: MW5061710
• Device Sequence Number: 1
• Product Code: IQI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 7704
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other; Required Intervention; Disability
• Patient Age: 35 YR
• Patient Weight: 97