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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device adaptor, hygiene
Product CodeILS
Regulation Number 890.5050
Device Class 1

MDR Year MDR Reports MDR Events
2019 50 50
2020 32 32
2021 27 27
2022 45 45
2023 59 59
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 35 35
Collapse 27 27
Material Twisted/Bent 22 22
Adverse Event Without Identified Device or Use Problem 21 21
Fracture 20 20
Material Integrity Problem 19 19
Insufficient Information 12 12
Material Fragmentation 12 12
Detachment of Device or Device Component 7 7
Appropriate Term/Code Not Available 6 6
Unintended Movement 6 6
Device Dislodged or Dislocated 5 5
Mechanical Problem 5 5
Material Separation 5 5
Unstable 3 3
Use of Device Problem 3 3
Structural Problem 3 3
Crack 3 3
Device Tipped Over 3 3
Misassembly by Users 3 3
Patient Device Interaction Problem 2 2
Sharp Edges 2 2
Human-Device Interface Problem 2 2
Installation-Related Problem 2 2
Product Quality Problem 2 2
Loose or Intermittent Connection 2 2
Defective Device 2 2
Defective Component 2 2
Material Deformation 2 2
Component Missing 1 1
Solder Joint Fracture 1 1
Improper or Incorrect Procedure or Method 1 1
Device Slipped 1 1
Corroded 1 1
Material Puncture/Hole 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Connection Problem 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 122 122
Head Injury 26 26
Laceration(s) 23 23
Bruise/Contusion 22 22
Bone Fracture(s) 20 20
Pain 12 12
Insufficient Information 10 10
No Clinical Signs, Symptoms or Conditions 9 9
Concussion 9 9
Limb Fracture 7 7
No Known Impact Or Consequence To Patient 5 5
Hip Fracture 4 4
Vertebral Fracture 4 4
Skin Tears 4 4
Swelling/ Edema 4 4
Muscle/Tendon Damage 3 3
Tooth Fracture 3 3
Neck Pain 3 3
Hemorrhage/Bleeding 3 3
Hematoma 2 2
Swelling 2 2
Damage to Ligament(s) 2 2
Abrasion 2 2
Unspecified Infection 2 2
Injury 2 2
Loss of consciousness 2 2
Joint Dislocation 2 2
No Consequences Or Impact To Patient 2 2
Easy Bruising 2 2
Intervertebral Disc Compression or Protrusion 2 2
Multiple Fractures 1 1
Blister 1 1
Skin Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Ulcer 1 1
Pressure Sores 1 1
Inadequate Pain Relief 1 1
Coma 1 1
Fracture, Arm 1 1
Unspecified Kidney or Urinary Problem 1 1
Post Traumatic Wound Infection 1 1
Needle Stick/Puncture 1 1
Memory Loss/Impairment 1 1
Vertigo 1 1
Loss of Range of Motion 1 1
Intracranial Hemorrhage 1 1
Erythema 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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