Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
splint, hand, and components
Product Code
ILH
Regulation Number
890.3475
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
5
5
2017
8
8
2018
2
2
2019
3
3
2021
2
2
2022
1
1
2023
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Patient-Device Incompatibility
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Insufficient Information
3
3
Fitting Problem
2
2
Pressure Problem
2
2
Device Operates Differently Than Expected
2
2
Device Contaminated During Manufacture or Shipping
1
1
Break
1
1
Defective Device
1
1
Use of Device Problem
1
1
Material Rupture
1
1
Device Contamination with Chemical or Other Material
1
1
Fracture
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
8
8
Rash
7
7
Swelling/ Edema
4
4
Device Embedded In Tissue or Plaque
4
4
Neuralgia
3
3
Itching Sensation
2
2
Burning Sensation
2
2
Swelling
2
2
Reaction
2
2
High Blood Pressure/ Hypertension
1
1
Arthralgia
1
1
Not Applicable
1
1
No Code Available
1
1
Inflammation
1
1
Local Reaction
1
1
Injury
1
1
Discomfort
1
1
Vomiting
1
1
Loss of Range of Motion
1
1
Peeling
1
1
Skin Tears
1
1
Wheal(s)
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
North Coast Medical Inc
II
Oct-19-2023
-
-