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
patient examination glove
Product Code
FMC
Regulation Number
880.6250
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
7
7
2015
41
41
2016
333
333
2017
32
32
2019
1
1
2020
1
1
2021
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Torn Material
215
215
Split
93
93
Crack
41
41
Material Integrity Problem
38
38
Break
26
26
Device Damaged Prior to Use
19
19
Hole In Material
16
16
Out-Of-Box Failure
10
10
Component or Accessory Incompatibility
8
8
Device Operates Differently Than Expected
6
6
Contamination
5
5
Fitting Problem
4
4
Packaging Problem
4
4
Adverse Event Without Identified Device or Use Problem
3
3
Device Contamination with Chemical or Other Material
3
3
Device Disinfection Or Sterilization Issue
2
2
Tear, Rip or Hole in Device Packaging
2
2
Defective Device
2
2
Product Quality Problem
2
2
Material Rupture
2
2
Inadequacy of Device Shape and/or Size
2
2
Component Falling
2
2
Nonstandard Device
2
2
Insufficient Information
2
2
Material Split, Cut or Torn
1
1
Device Fell
1
1
Therapeutic or Diagnostic Output Failure
1
1
Device Emits Odor
1
1
Material Puncture/Hole
1
1
Detachment Of Device Component
1
1
Use of Device Problem
1
1
Material Perforation
1
1
Material Discolored
1
1
Disconnection
1
1
Patient-Device Incompatibility
1
1
Failure to Cut
1
1
Cut In Material
1
1
Device-Device Incompatibility
1
1
Compatibility Problem
1
1
Mechanics Altered
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
258
258
No Patient Involvement
125
125
No Consequences Or Impact To Patient
14
14
No Information
7
7
Reaction
4
4
Swelling
2
2
Injury
2
2
Insufficient Information
2
2
Discharge
1
1
Chemical Exposure
1
1
No Code Available
1
1
Exposure to Body Fluids
1
1
Hepatitis
1
1
Hypersensitivity/Allergic reaction
1
1
Unspecified Infection
1
1
Inflammation
1
1
Rash
1
1
Sepsis
1
1
Skin Discoloration
1
1
Skin Irritation
1
1
-
-