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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
Product CodeCCX
Regulation Number 868.6820
Device Class 1

MDR Year MDR Reports MDR Events
2019 14 14
2020 13 13
2021 26 26
2022 13 13
2023 11 11
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 13 13
Break 12 12
Patient Device Interaction Problem 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Unintended Movement 7 7
Positioning Failure 7 7
Material Integrity Problem 4 4
Mechanical Problem 4 4
Fracture 4 4
Device Slipped 3 3
Patient-Device Incompatibility 3 3
Detachment of Device or Device Component 3 3
Appropriate Term/Code Not Available 3 3
Component or Accessory Incompatibility 2 2
Component Missing 2 2
Use of Device Problem 2 2
Positioning Problem 2 2
Defective Device 2 2
Material Split, Cut or Torn 1 1
Device-Device Incompatibility 1 1
Material Puncture/Hole 1 1
Device Fell 1 1
Contamination /Decontamination Problem 1 1
Material Discolored 1 1
Material Too Rigid or Stiff 1 1
Structural Problem 1 1
No Apparent Adverse Event 1 1
Material Separation 1 1
Product Quality Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unsealed Device Packaging 1 1
Connection Problem 1 1
Physical Resistance/Sticking 1 1
Activation Problem 1 1
Material Deformation 1 1
Protective Measures Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Loose or Intermittent Connection 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
Pressure Sores 14 14
No Known Impact Or Consequence To Patient 10 10
Skin Inflammation/ Irritation 8 8
Rash 5 5
Insufficient Information 5 5
Unspecified Tissue Injury 5 5
Burn(s) 4 4
Erythema 4 4
Fall 3 3
Tissue Breakdown 3 3
Abrasion 2 2
Blister 2 2
Injury 2 2
No Patient Involvement 2 2
Ulcer 2 2
No Consequences Or Impact To Patient 2 2
Bruise/Contusion 2 2
Superficial (First Degree) Burn 1 1
Skull Fracture 1 1
Head Injury 1 1
Scarring 1 1
Laceration(s) 1 1
Tissue Damage 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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