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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stretcher, hand-carried
Product CodeFPP
Regulation Number 880.6900
Device Class 1

MDR Year MDR Reports MDR Events
2014 118 118
2015 119 119
2016 11 11
2017 90 90
2018 154 154
2019 33 174
2020 31 218
2021 54 313
2022 36 362
2023 41 393
2024 7 85

Device Problems MDRs with this Device Problem Events in those MDRs
Break 186 186
Component Missing 88 96
Device Operates Differently Than Expected 82 82
Difficult or Delayed Positioning 80 1264
Device Slipped 45 45
Detachment Of Device Component 39 39
Difficult to Fold, Unfold or Collapse 38 69
Protective Measures Problem 32 97
Mechanical Problem 32 32
Crack 30 30
Device Fell 27 42
Bent 22 22
Naturally Worn 22 22
Unintended System Motion 21 21
Device Inoperable 20 20
Device Tipped Over 12 12
Loose or Intermittent Connection 12 12
Sticking 12 12
Sharp Edges 11 18
Collapse 8 8
Detachment of Device or Device Component 8 8
Connection Problem 7 7
Structural Problem 6 39
Insufficient Information 6 6
Mechanics Altered 6 6
Unintended Movement 5 5
Mechanical Jam 5 7
Adverse Event Without Identified Device or Use Problem 5 5
Unstable 5 5
Appropriate Term/Code Not Available 4 4
Failure to Align 4 4
Torn Material 3 3
Positioning Problem 3 3
Material Integrity Problem 3 3
Improper Device Output 2 2
Fail-Safe Problem 2 2
Failure to Fold 2 2
Cut In Material 2 2
Patient Device Interaction Problem 2 2
Physical Resistance/Sticking 2 2
Device Damaged by Another Device 1 1
Material Separation 1 1
Positioning Failure 1 1
Failure to Discharge 1 1
Difficult To Position 1 1
Stretched 1 1
Split 1 1
Component Falling 1 1
Disconnection 1 1
Premature Separation 1 1
Scratched Material 1 1
Device Damaged Prior to Use 1 1
Malposition of Device 1 1
Misassembled 1 1
Device Difficult to Setup or Prepare 1 1
Device Dislodged or Dislocated 1 1
Activation, Positioning or Separation Problem 1 1
Loss of or Failure to Bond 1 1
Defective Component 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Advance 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure To Adhere Or Bond 1 1
Patient-Device Incompatibility 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 362 362
No Clinical Signs, Symptoms or Conditions 131 1237
No Consequences Or Impact To Patient 94 96
No Patient Involvement 50 317
Injury 22 22
Pain 16 16
Insufficient Information 10 100
Fall 9 9
Laceration(s) 7 7
Bruise/Contusion 6 6
Muscle/Tendon Damage 5 5
Abrasion 4 3
Bone Fracture(s) 2 2
Discomfort 2 2
No Information 2 2
No Code Available 1 1
Deformity/ Disfigurement 1 1
Skin Discoloration 1 1
Spinal Column Injury 1 1
Sprain 1 1
Vomiting 1 1
Hemorrhage/Bleeding 1 1
Muscle Spasm(s) 1 1
Muscle Weakness 1 3
Asthma 1 1
Erythema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Paramed Systems II Dec-28-2009
2 Stryker Medical Div. of Stryker Corporation II Nov-09-2009
3 Stryker Medical Div. of Stryker Corporation II Feb-04-2009
4 Stryker Medical Division of Stryker Corporation II Feb-06-2012
5 Stryker Medical Division of Stryker Corporation II Aug-11-2011
6 Winco Mfg., LLC II Oct-10-2016
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