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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 7 7

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
Unintended Movement 6 6
Detachment of Device or Device Component 6 6
Device Dislodged or Dislocated 5 5
Appropriate Term/Code Not Available 5 5
Material Separation 5 5
Mechanical Problem 4 4
Crack 3 3
Unstable 3 3
Structural Problem 3 3
Misassembly by Users 3 3
Device Tipped Over 3 3
Human-Device Interface Problem 2 2
Installation-Related Problem 2 2
Patient Device Interaction Problem 2 2
Sharp Edges 2 2
Defective Device 2 2
Defective Component 2 2
Use of Device Problem 2 2
Product Quality Problem 2 2
Loose or Intermittent Connection 2 2
Material Deformation 2 2
Corroded 1 1
Material Puncture/Hole 1 1
Improper or Incorrect Procedure or Method 1 1
Device Slipped 1 1
Component Missing 1 1
Solder Joint Fracture 1 1
No Apparent Adverse Event 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Connection Problem 1 1
Material Protrusion/Extrusion 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) 19 19
Pain 12 12
Concussion 9 9
Insufficient Information 9 9
No Clinical Signs, Symptoms or Conditions 9 9
Limb Fracture 7 7
No Known Impact Or Consequence To Patient 5 5
Hip Fracture 4 4
Swelling/ Edema 4 4
Vertebral Fracture 4 4
Muscle/Tendon Damage 3 3
Tooth Fracture 3 3
Neck Pain 3 3
Skin Tears 3 3
Hemorrhage/Bleeding 3 3
Hematoma 2 2
No Consequences Or Impact To Patient 2 2
Swelling 2 2
Damage to Ligament(s) 2 2
Loss of consciousness 2 2
Joint Dislocation 2 2
Abrasion 2 2
Injury 2 2
Intervertebral Disc Compression or Protrusion 2 2
Easy Bruising 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Blister 1 1
Skin Infection 1 1
Fracture, Arm 1 1
Post Traumatic Wound Infection 1 1
Needle Stick/Puncture 1 1
Inadequate Pain Relief 1 1
Coma 1 1
Unspecified Kidney or Urinary Problem 1 1
Multiple Fractures 1 1
Memory Loss/Impairment 1 1
Loss of Range of Motion 1 1
Vertigo 1 1
Pressure Sores 1 1
Intracranial Hemorrhage 1 1
Unspecified Infection 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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