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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adaptor, hygiene
Regulation Description Daily activity assist device.
Product CodeILS
Regulation Number 890.5050
Device Class 1

MDR Year MDR Reports MDR Events
2020 32 32
2021 27 27
2022 45 45
2023 59 59
2024 37 37
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 29 29
Material Integrity Problem 24 24
Collapse 22 22
Fracture 21 21
Insufficient Information 17 17
Material Twisted/Bent 17 17
Adverse Event Without Identified Device or Use Problem 14 14
Appropriate Term/Code Not Available 11 11
Unintended Movement 7 7
Mechanical Problem 6 6
Material Fragmentation 6 6
Detachment of Device or Device Component 5 5
Device Tipped Over 4 4
Misassembly by Users 4 4
Device Dislodged or Dislocated 4 4
Loose or Intermittent Connection 4 4
Unstable 3 3
Crack 3 3
Use of Device Problem 3 3
Material Separation 3 3
Defective Component 2 2
Structural Problem 2 2
Installation-Related Problem 2 2
Human-Device Interface Problem 2 2
Device Slipped 1 1
Material Puncture/Hole 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Patient Device Interaction Problem 1 1
Component Missing 1 1
Sharp Edges 1 1
Solder Joint Fracture 1 1
Material Deformation 1 1
Product Quality Problem 1 1
No Apparent Adverse Event 1 1
Connection Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 99 99
Head Injury 25 25
Laceration(s) 20 20
Bruise/Contusion 19 19
Bone Fracture(s) 19 19
Insufficient Information 16 16
No Clinical Signs, Symptoms or Conditions 12 12
Limb Fracture 10 10
Pain 9 9
Concussion 9 9
Vertebral Fracture 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Hip Fracture 4 4
Swelling/ Edema 4 4
Skin Tears 3 3
Muscle/Tendon Damage 3 3
Neck Pain 3 3
Loss of consciousness 2 2
Intervertebral Disc Compression or Protrusion 2 2
Coma 2 2
Easy Bruising 2 2
Muscle Weakness 2 2
Hematoma 2 2
Brain Injury 2 2
Unspecified Infection 2 2
Needle Stick/Puncture 1 1
Loss of Range of Motion 1 1
Vertigo 1 1
Intracranial Hemorrhage 1 1
Blister 1 1
Tooth Fracture 1 1
Abrasion 1 1
Multiple Fractures 1 1
Unspecified Kidney or Urinary Problem 1 1
Memory Loss/Impairment 1 1
Ulcer 1 1
Joint Dislocation 1 1
Hemorrhage/Bleeding 1 1
No Consequences Or Impact To Patient 1 1
Pressure Sores 1 1
Skin Infection 1 1
Fracture, Arm 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Gf Health Products II Apr-05-2021
2 James Leckey Design Ltd II Apr-08-2020
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