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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device patient examination glove
Product CodeFMC
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

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