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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device chair, with casters
Product CodeINM
Regulation Number 890.3100
Device Class 1

MDR Year MDR Reports MDR Events
2016 18 18
2017 8 8
2018 11 11
2019 13 13
2020 9 9
2021 22 22
2022 11 13
2023 11 11
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Misassembly by Users 16 16
Break 15 15
Adverse Event Without Identified Device or Use Problem 11 11
Detachment of Device or Device Component 9 9
Use of Device Problem 8 8
Unintended Movement 6 6
Device Fell 5 5
Device Operates Differently Than Expected 4 4
Collapse 4 4
Device Tipped Over 3 3
Insufficient Information 3 3
Misassembled During Installation 2 2
Defective Component 2 2
Improper or Incorrect Procedure or Method 2 2
Disconnection 2 2
Fracture 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Unintended System Motion 2 2
Device Slipped 2 2
Device Inoperable 1 1
Unstable 1 1
Detachment Of Device Component 1 1
Crack 1 1
Material Fragmentation 1 1
Fitting Problem 1 1
Loss of or Failure to Bond 1 1
Connection Problem 1 1
Misassembly During Maintenance/Repair 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Sharp Edges 1 3
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 44 44
Head Injury 15 15
Bone Fracture(s) 14 14
No Clinical Signs, Symptoms or Conditions 13 15
Laceration(s) 9 9
Bruise/Contusion 8 8
Injury 8 8
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 4 4
No Consequences Or Impact To Patient 3 3
Pain 3 3
Cellulitis 2 2
Hemorrhage/Bleeding 2 2
Abrasion 2 2
Concussion 2 2
Brain Injury 2 2
No Information 2 2
No Code Available 1 1
Hydrocephalus 1 1
Unspecified Tissue Injury 1 1
Unspecified Infection 1 1
Hip Fracture 1 1
Tooth Fracture 1 1
Neck Pain 1 1
Death 1 1
Sprain 1 1
Swelling 1 1
Vomiting 1 1
Weakness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accora Inc II Sep-13-2021
2 Ki Mobility Llc III Jan-07-2022
3 R82 A/S II May-11-2019
4 R82 A/S II Nov-09-2018
5 Sunrise Medical (US) LLC II Jul-28-2021
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