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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device pouch, colostomy
Product CodeEZQ
Regulation Number 876.5900
Device Class 1

MDR Year MDR Reports MDR Events
2017 7 7
2018 342 342
2019 246 246
2020 381 381
2021 118 118
2022 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 970 970
Sharp Edges 79 79
Positioning Problem 47 47
Adverse Event Without Identified Device or Use Problem 33 33
Fluid Leak 25 25
Appropriate Term/Code Not Available 20 20
Material Too Rigid or Stiff 15 15
Product Quality Problem 4 4
Material Integrity Problem 2 2
Device Handling Problem 2 2
Loss of or Failure to Bond 2 2
Nonstandard Device 2 2
Off-Label Use 1 1
Material Puncture/Hole 1 1
Break 1 1
Burst Container or Vessel 1 1
Use of Device Problem 1 1
Insufficient Information 1 1
Patient-Device Incompatibility 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 738 738
No Patient Involvement 143 143
No Clinical Signs, Symptoms or Conditions 80 80
Tissue Damage 43 43
Skin Irritation 37 37
Distress 25 25
Blood Loss 24 24
Hemorrhage/Bleeding 23 23
Skin Inflammation/ Irritation 20 20
Tissue Breakdown 9 9
Urinary Tract Infection 9 9
Itching Sensation 8 8
Laceration(s) 8 8
Rash 7 7
Hypersensitivity/Allergic reaction 5 5
Erythema 5 5
No Known Impact Or Consequence To Patient 5 5
Fungal Infection 4 4
Discomfort 3 3
Unspecified Infection 3 3
Skin Discoloration 3 3
Pain 3 3
Bacterial Infection 2 2
Reaction 2 2
Blister 2 2
Skin Infection 1 1
Skin Inflammation 1 1
Contact Dermatitis 1 1
Cellulitis 1 1
Abrasion 1 1
Inflammation 1 1
Burning Sensation 1 1
Ulcer 1 1
Urticaria 1 1

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