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TPLC
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Device
bedding, disposable, medical
Regulation Description
Medical disposable bedding.
Product Code
KME
Regulation Number
880.6060
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
5
5
2021
2
2
2022
1
1
2023
2
2
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Split, Cut or Torn
4
4
Material Integrity Problem
2
2
Adverse Event Without Identified Device or Use Problem
1
1
Material Disintegration
1
1
Display or Visual Feedback Problem
1
1
Device-Device Incompatibility
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5
5
No Known Impact Or Consequence To Patient
3
3
Skin Inflammation/ Irritation
1
1
Rash
1
1
Fracture, Arm
1
1
Caustic/Chemical Burns
1
1
Skin Burning Sensation
1
1
Itching Sensation
1
1
Localized Skin Lesion
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Microtek Medical Inc.
II
Jul-28-2023
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