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