FOOT SPLINT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-23 for FOOT SPLINT manufactured by Darco.

Event Text Entries

[55886501] Double knee replacements needed after 2 weeks of use of a plantar fascitis night splint. I wore a night splint for my foot. The podiatrist thought i had plantars fascitis on both feet. Dr. (b)(6) gave me a night splint (darco brand). I wore it on both feet dr (b)(6) recommended. Since insurance would cover only 1 device. After 2 weeks i woke up one day and fell into the wall in my house. I could not walk without help. When i went to the orthopedic dr (b)(6), he said i needed double knee replacements. My cartilage in my knees wore away within 2 weeks of use of the splint device. My friend (b)(6) also claims her knees hurt worse after using the device. My theory is that i have undiagnosed tarsal tunnel syndrome, and stretching the ligament in my foot made it worse. Since the tendon could not slide back into place, and was left in an extended position. I am now dependent on crutches, or use of a wheelchair for long distances. Of course the doctors at (b)(6) deny the device caused this since one of the doctors at (b)(6) is married to the podiatrist. I am not blaming dr (b)(6). I am blaming the device company=darco.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5065035
• MDR Report Key: 5979796
• Date Received: 2016-09-23
• Date of Report: 2016-09-23
• Date of Event: 2015-06-11
• Date Added to Maude: 2016-09-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: FOOT SPLINT
• Generic Name: FOOT SPLINT
• Product Code: NOC
• Date Received: 2016-09-23
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DARCO

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2016-09-23