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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
2014 3 3
2015 16 16
2016 26 26
2017 21 21
2018 22 22
2019 29 37
2020 43 59
2021 30 67
2022 32 90
2023 22 86
2024 17 62

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 57 57
Mechanical Problem 25 116
Mechanical Jam 21 88
Device Slipped 19 19
Break 19 19
Device Operates Differently Than Expected 17 17
Device Fell 16 76
Improper or Incorrect Procedure or Method 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Detachment of Device or Device Component 7 7
Use of Device Problem 7 7
Sharp Edges 7 13
Crack 6 6
Collapse 6 6
Detachment Of Device Component 5 5
Insufficient Information 5 5
Fracture 5 5
Misassembly by Users 5 5
Unintended Movement 4 4
Bent 4 4
Unstable 3 3
Device Tipped Over 3 3
Unintended System Motion 3 3
Naturally Worn 2 2
Device Dislodged or Dislocated 2 5
Patient Device Interaction Problem 2 2
Material Integrity Problem 2 2
Defective Component 2 2
Folded 1 1
Device Unsafe to Use in Environment 1 1
Structural Problem 1 2
Sticking 1 1
Positioning Failure 1 1
Electrical Shorting 1 1
Device Contamination with Chemical or Other Material 1 1
Component Misassembled 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Appropriate Term/Code Not Available 1 1
Defective Device 1 1
Connection Problem 1 1
Patient-Device Incompatibility 1 1
Entrapment of Device 1 1
Device Contaminated at the User Facility 1 1
Pressure Problem 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 101 307
No Known Impact Or Consequence To Patient 64 64
Fall 25 25
No Consequences Or Impact To Patient 17 17
No Patient Involvement 14 36
Bone Fracture(s) 13 13
Injury 11 11
Insufficient Information 6 6
Pain 6 6
No Information 5 5
Head Injury 4 4
Tooth Fracture 3 3
Laceration(s) 3 3
Bruise/Contusion 3 3
Encephalopathy 1 1
Damage to Ligament(s) 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
No Code Available 1 1
Bowel Perforation 1 1
Hematoma 1 1
Abrasion 1 1
Contusion 1 1
Weakness 1 1
Burning Sensation 1 1
Strangulation 1 1
Concussion 1 1
Hemorrhage, Cerebral 1 1
Physical Entrapment 1 1
Hemorrhage/Bleeding 1 1
Pressure Sores 1 1
Deformity/ Disfigurement 1 1
Vertebral Fracture 1 1
Urinary Tract Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Altimate Medical, Inc. II Jan-04-2023
2 Etac Supply Center Ab II Jul-25-2013
3 Invacare Corporation II Jul-09-2014
4 Invacare Corporation II Nov-05-2013
5 Patterson Medical Holdings, Inc. II Sep-10-2009
6 R82 A/S II Feb-08-2022
7 Stryker Medical Division of Stryker Corporation II Aug-06-2021
8 Uplift Technologies Inc. II Nov-22-2011
9 Winco Mfg., LLC II Aug-14-2015
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