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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 8 12

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 55 55
Mechanical Problem 23 89
Device Slipped 19 19
Break 19 19
Mechanical Jam 19 71
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
Sharp Edges 6 11
Collapse 6 6
Crack 6 6
Use of Device Problem 6 6
Detachment of Device or Device Component 6 6
Fracture 5 5
Detachment Of Device Component 5 5
Misassembly by Users 5 5
Insufficient Information 5 5
Unintended Movement 4 4
Bent 4 4
Unintended System Motion 3 3
Unstable 3 3
Device Tipped Over 3 3
Material Integrity Problem 2 2
Naturally Worn 2 2
Device Dislodged or Dislocated 2 5
Defective Component 2 2
Patient Device Interaction Problem 2 2
Component Misassembled 1 1
Appropriate Term/Code Not Available 1 1
Pressure Problem 1 1
Device Contaminated at the User Facility 1 1
Structural Problem 1 2
Defective Device 1 1
Sticking 1 1
Positioning Failure 1 1
Entrapment of Device 1 1
Component Falling 1 1
Electrical Shorting 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Folded 1 1
Patient-Device Incompatibility 1 1
Connection Problem 1 1
Device Unsafe to Use in Environment 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 93 258
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
Bruise/Contusion 3 3
Laceration(s) 3 3
Tooth Fracture 3 3
Abrasion 1 1
Deformity/ Disfigurement 1 1
No Code Available 1 1
Vertebral Fracture 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Bowel Perforation 1 1
Damage to Ligament(s) 1 1
Pressure Sores 1 1
Strangulation 1 1
Urinary Tract Infection 1 1
Weakness 1 1
Burning Sensation 1 1
Concussion 1 1
Contusion 1 1
Death 1 1
Encephalopathy 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Hemorrhage, Cerebral 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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