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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 bedding, disposable, medical
Product CodeKME
Regulation Number 880.6060
Device Class 1

MDR Year MDR Reports MDR Events
2019 7 7
2020 5 5
2021 2 2
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 3 3
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 2 2
Patient Device Interaction Problem 1 1
Accessory Incompatible 1 1
Material Disintegration 1 1
Display or Visual Feedback Problem 1 1
Excess Flow or Over-Infusion 1 1
Off-Label Use 1 1
Device Slipped 1 1
Inadequate or Insufficient Training 1 1
Improper or Incorrect Procedure or Method 1 1
Incomplete or Missing Packaging 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 2 2
Pressure Sores 2 2
Fracture, Arm 1 1
Burn, Thermal 1 1
Caustic/Chemical Burns 1 1
Adult Respiratory Distress Syndrome 1 1
Burn(s) 1 1
Itching Sensation 1 1
Rash 1 1
Swelling 1 1
Vomiting 1 1
No Consequences Or Impact To Patient 1 1
No Information 1 1
Skin Burning Sensation 1 1
Localized Skin Lesion 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Microtek Medical Inc. II Jul-28-2023
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