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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chair, adjustable, mechanical
Product CodeINN
Regulation Number 890.3100
Device Class 1

MDR Year MDR Reports MDR Events
2018 22 22
2019 29 37
2020 43 59
2021 30 67
2022 32 90
2023 9 44

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 52 52
Mechanical Problem 16 66
Mechanical Jam 16 59
Device Fell 14 66
Break 11 11
Device Operates Differently Than Expected 6 6
Sharp Edges 5 10
Misassembly by Users 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Device Slipped 4 4
Improper or Incorrect Procedure or Method 4 4
Fracture 4 4
Detachment of Device or Device Component 4 4
Use of Device Problem 3 3
Collapse 3 3
Insufficient Information 3 3
Patient Device Interaction Problem 2 2
Unintended Movement 2 2
Device Dislodged or Dislocated 2 5
Device Tipped Over 2 2
Defective Component 1 1
Structural Problem 1 2
Defective Device 1 1
Crack 1 1
Positioning Failure 1 1
Unstable 1 1
Unintended System Motion 1 1
Electrical Shorting 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Unsafe to Use in Environment 1 1
Pressure Problem 1 1
Naturally Worn 1 1
Device Contaminated at the User Facility 1 1
Component Misassembled 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 77 209
No Known Impact Or Consequence To Patient 38 38
No Patient Involvement 13 35
Fall 12 12
No Consequences Or Impact To Patient 8 8
Bone Fracture(s) 6 6
Pain 4 4
Injury 3 3
Insufficient Information 3 3
Tooth Fracture 2 2
Head Injury 2 2
Hematoma 1 1
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Abrasion 1 1
Bruise/Contusion 1 1
Contusion 1 1
Encephalopathy 1 1
Pressure Sores 1 1
Strangulation 1 1
Urinary Tract Infection 1 1
Concussion 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Bowel Perforation 1 1
Vertebral Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Altimate Medical, Inc. II Jan-04-2023
2 R82 A/S II Feb-08-2022
3 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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