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TPLC
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show TPLC since
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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
Packaging Problem
4
4
Fitting Problem
4
4
Adverse Event Without Identified Device or Use Problem
3
3
Device Contamination with Chemical or Other Material
3
3
Defective Device
2
2
Material Rupture
2
2
Insufficient Information
2
2
Device Disinfection Or Sterilization Issue
2
2
Inadequacy of Device Shape and/or Size
2
2
Tear, Rip or Hole in Device Packaging
2
2
Product Quality Problem
2
2
Nonstandard Device
2
2
Component Falling
2
2
Therapeutic or Diagnostic Output Failure
1
1
Use of Device Problem
1
1
Material Discolored
1
1
Mechanics Altered
1
1
Failure to Cut
1
1
Material Perforation
1
1
Cut In Material
1
1
Compatibility Problem
1
1
Material Split, Cut or Torn
1
1
Device-Device Incompatibility
1
1
Disconnection
1
1
Patient-Device Incompatibility
1
1
Material Puncture/Hole
1
1
Device Fell
1
1
Device Emits Odor
1
1
Detachment Of Device Component
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
Injury
2
2
Swelling
2
2
Insufficient Information
2
2
Unspecified Infection
1
1
Hypersensitivity/Allergic reaction
1
1
Sepsis
1
1
No Code Available
1
1
Skin Irritation
1
1
Inflammation
1
1
Chemical Exposure
1
1
Skin Discoloration
1
1
Rash
1
1
Hepatitis
1
1
Exposure to Body Fluids
1
1
Discharge
1
1
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