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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 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 15 15
Patient Device Interaction Problem 12 12
Unintended Movement 11 11
Break 9 9
Insufficient Information 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Fracture 7 7
Device Slipped 4 4
Material Integrity Problem 4 4
Appropriate Term/Code Not Available 3 3
Mechanical Problem 3 3
Use of Device Problem 2 2
Defective Device 2 2
Device Tipped Over 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
Material Split, Cut or Torn 1 1
Sharp Edges 1 1
Device Fell 1 1
Excessive Heating 1 1
Activation Problem 1 1
Device-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Contamination /Decontamination Problem 1 1
Component Missing 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Material Fragmentation 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 57 57
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
Discomfort 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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