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TPLC
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show TPLC since
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Device
bedding, disposable, medical
Product Code
KME
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
2021
2
2
2022
1
1
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3
3
Insufficient Information
3
3
Material Split, Cut or Torn
3
3
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
Device-Device Incompatibility
1
1
Torn Material
1
1
Patient Device Interaction Problem
1
1
Component Falling
1
1
Contamination
1
1
Deflation Problem
1
1
Material Disintegration
1
1
Display or Visual Feedback 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
No Clinical Signs, Symptoms or Conditions
3
3
Rash
2
2
Partial thickness (Second Degree) Burn
2
2
Full thickness (Third Degree) Burn
2
2
Injury
2
2
Hip Fracture
1
1
Fracture, Arm
1
1
Burn, Thermal
1
1
Caustic/Chemical Burns
1
1
No Information
1
1
Skin Burning Sensation
1
1
Localized Skin Lesion
1
1
Skin Inflammation/ Irritation
1
1
Swelling
1
1
Vomiting
1
1
No Consequences Or Impact To Patient
1
1
Head Injury
1
1
Hematoma
1
1
Itching Sensation
1
1
Adult Respiratory Distress Syndrome
1
1
Burn(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
LITTLE RAPIDS CORPORATION
II
Jan-09-2018
2
Microtek Medical Inc.
II
Jul-28-2023
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