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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device support, patient position
Regulation Description Patient position support.
Product CodeCCX
Regulation Number 868.6820
Device Class 1

MDR Year MDR Reports MDR Events
2020 13 13
2021 26 26
2022 13 13
2023 11 11
2024 23 23
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10 10
Positioning Failure 10 10
Insufficient Information 9 9
Patient Device Interaction Problem 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Unintended Movement 6 6
Fracture 5 5
Mechanical Problem 4 4
Material Integrity Problem 4 4
Appropriate Term/Code Not Available 3 3
Patient-Device Incompatibility 3 3
Use of Device Problem 2 2
Component or Accessory Incompatibility 2 2
Positioning Problem 2 2
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Device Fell 1 1
Activation Problem 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Component Missing 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Device Slipped 1 1
Loose or Intermittent Connection 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
Pressure Sores 12 12
Skin Inflammation/ Irritation 8 8
Insufficient Information 6 6
Rash 5 5
Unspecified Tissue Injury 5 5
Fall 4 4
No Known Impact Or Consequence To Patient 3 3
Burn(s) 3 3
Erythema 3 3
Tissue Breakdown 3 3
Blister 2 2
Abrasion 2 2
No Patient Involvement 2 2
Ulcer 2 2
Bruise/Contusion 2 2
Superficial (First Degree) Burn 1 1
Skull Fracture 1 1
Head Injury 1 1
Laceration(s) 1 1
Skin Tears 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aspen Surgical Products, Inc. II Aug-30-2021
2 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
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