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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bed, therapeutic, ac-powered, adjustable home-use
Product CodeLLI
Regulation Number 880.5100
Device Class 2

MDR Year MDR Reports MDR Events
2018 17 17
2019 95 95
2020 16 16
2021 3 3
2022 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 76 76
Temperature Problem 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Unintended Movement 4 4
Improper or Incorrect Procedure or Method 4 4
Thermal Decomposition of Device 3 3
Fire 3 3
Device Slipped 3 3
Material Integrity Problem 3 3
Material Protrusion/Extrusion 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 2 2
Separation Problem 2 2
Smoking 2 2
Material Puncture/Hole 2 2
Use of Device Problem 2 2
Patient-Device Incompatibility 2 2
Installation-Related Problem 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Human-Device Interface Problem 1 1
Component or Accessory Incompatibility 1 1
Material Perforation 1 1
Unstable 1 1
Material Fragmentation 1 1
Melted 1 1
Misassembled 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Misassembled During Installation 1 1
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Explosion 1 1
Sharp Edges 1 1
Device Fell 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 74 74
Fall 29 29
No Known Impact Or Consequence To Patient 16 16
Laceration(s) 9 9
Injury 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Hematoma 4 4
Swelling 2 2
Bone Fracture(s) 2 2
Abrasion 2 2
Bruise/Contusion 1 1
Burn(s) 1 1
Death 1 1
Eye Injury 1 1
Pain 1 1
Shock 1 1
Physical Entrapment 1 1
Missing Value Reason 1 1
Unspecified Respiratory Problem 1 1
Multiple Fractures 1 1
Electric Shock 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Craftmatic Industries, Inc. II Aug-04-2022
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