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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
2021 26 26
2022 13 13
2023 11 11
2024 23 23
2025 22 22
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 15 15
Patient Device Interaction Problem 12 12
Insufficient Information 9 9
Break 8 8
Unintended Movement 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Fracture 6 6
Device Slipped 3 3
Mechanical Problem 3 3
Material Integrity Problem 3 3
Appropriate Term/Code Not Available 3 3
Component or Accessory Incompatibility 2 2
Device Tipped Over 2 2
Use of Device Problem 2 2
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
Positioning 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
No Apparent Adverse Event 1 1
Protective Measures Problem 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
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
Abrasion 3 3
Fall 3 3
Tissue Breakdown 3 3
Bruise/Contusion 3 3
Ulcer 2 2
Partial thickness (Second Degree) Burn 2 2
Superficial (First Degree) Burn 1 1
Head Injury 1 1
Burn(s) 1 1
Laceration(s) 1 1
Skin Tears 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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