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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aid, transfer
Product CodeIKX
Regulation Number 890.5050
Device Class 1

MDR Year MDR Reports MDR Events
2019 14 14
2020 11 11
2021 5 5
2022 50 50
2023 12 12
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 44 44
Break 11 11
Insufficient Information 7 7
Mechanical Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Detachment of Device or Device Component 4 4
Patient-Device Incompatibility 3 3
Entrapment of Device 2 2
Loose or Intermittent Connection 1 1
Crack 1 1
Collapse 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Material Separation 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Misassembled 1 1
Material Split, Cut or Torn 1 1
Loss of or Failure to Bond 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 52 52
Fall 12 12
No Consequences Or Impact To Patient 4 4
Physical Entrapment 4 4
Pain 4 4
Strangulation 3 3
No Known Impact Or Consequence To Patient 3 3
Death 3 3
Insufficient Information 3 3
Bone Fracture(s) 3 3
Abrasion 3 3
Laceration(s) 2 2
Bruise/Contusion 1 1
Hip Fracture 1 1
Joint Dislocation 1 1
Blood Loss 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Information 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Concussion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medline Industries Inc II Oct-05-2020
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