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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 18 18

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 9 9
Fracture 9 9
Device Slipped 4 4
Material Integrity Problem 4 4
Positioning Problem 4 4
Mechanical Problem 3 3
Appropriate Term/Code Not Available 3 3
Component or Accessory Incompatibility 2 2
Device Tipped Over 2 2
Peeled/Delaminated 2 2
Defective Device 2 2
Use of Device Problem 2 2
Detachment of Device or Device Component 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
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
Sharp Edges 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 63 63
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
Fall 4 4
Abrasion 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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