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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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

MDR Year MDR Reports MDR Events
2015 2 2
2016 2 2
2017 6 6
2019 7 7
2020 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Insufficient Information 3 3
Material Split, Cut or Torn 2 2
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Fragmentation 2 2
Excess Flow or Over-Infusion 1 1
Device Emits Odor 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
Device Damaged Prior to Use 1 1
Incomplete or Missing Packaging 1 1
Device Operates Differently Than Expected 1 1
Torn Material 1 1
Component Falling 1 1
Contamination 1 1
Deflation Problem 1 1
Accessory Incompatible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 5 5
No Known Impact Or Consequence To Patient 5 5
Fall 4 4
Injury 2 2
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 2 2
No Information 1 1
Adult Respiratory Distress Syndrome 1 1
Burn(s) 1 1
Hip Fracture 1 1
Fracture, Arm 1 1
Burn, Thermal 1 1
Head Injury 1 1
Hematoma 1 1
Rash 1 1
Swelling 1 1
Vomiting 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LITTLE RAPIDS CORPORATION II Jan-09-2018
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