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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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 15 15
Patient Device Interaction Problem 12 12
Break 10 10
Insufficient Information 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Unintended Movement 7 7
Fracture 5 5
Mechanical Problem 4 4
Material Integrity Problem 4 4
Patient-Device Incompatibility 3 3
Appropriate Term/Code Not Available 3 3
Component or Accessory Incompatibility 2 2
Positioning Problem 2 2
Use of Device Problem 2 2
Device Slipped 1 1
Device-Device Incompatibility 1 1
Material Split, Cut or Torn 1 1
Activation Problem 1 1
Material Puncture/Hole 1 1
Device Fell 1 1
Unsealed Device Packaging 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Contamination /Decontamination Problem 1 1
Material Fragmentation 1 1
Material Discolored 1 1
Material Too Rigid or Stiff 1 1
Component Missing 1 1
Material Deformation 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Protective Measures Problem 1 1
Excessive Heating 1 1
Connection Problem 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
Pressure Sores 12 12
Skin Inflammation/ Irritation 8 8
Insufficient Information 6 6
Rash 5 5
Erythema 5 5
Unspecified Tissue Injury 5 5
Blister 4 4
Burn(s) 4 4
Fall 4 4
Abrasion 3 3
No Known Impact Or Consequence To Patient 3 3
Tissue Breakdown 3 3
Bruise/Contusion 3 3
No Patient Involvement 2 2
Ulcer 2 2
Partial thickness (Second Degree) Burn 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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