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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stretcher, wheeled, powered
Product CodeINK
Regulation Number 890.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM CO.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRANSMOTION MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
WINCO MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1
WINCO MFG., LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 88 88
2015 4 4
2016 5 5
2017 5 5
2018 63 146
2019 79 328
2020 89 295
2021 114 308
2022 93 393
2023 147 527
2024 26 132

Device Problems MDRs with this Device Problem Events in those MDRs
Intermittent Loss of Power 121 507
Mechanical Jam 89 276
Unintended System Motion 89 480
Electrical /Electronic Property Problem 85 255
Grounding Malfunction 60 153
Mechanical Problem 57 147
Break 48 48
Device Slipped 37 40
Positioning Problem 32 34
Unintended Movement 31 88
Fluid/Blood Leak 26 150
Sharp Edges 25 37
Device Stops Intermittently 18 21
Positioning Failure 14 16
Device Inoperable 13 13
Insufficient Information 11 11
Device Fell 10 10
Device Operates Differently Than Expected 8 8
Naturally Worn 5 5
Patient Device Interaction Problem 5 5
Defective Component 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Scratched Material 3 3
Unintended Electrical Shock 2 2
Improper or Incorrect Procedure or Method 2 2
Sticking 2 2
Fire 2 2
Peeled/Delaminated 2 2
Loss of Power 1 1
Material Separation 1 1
Kinked 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 1 1
False Reading From Device Non-Compliance 1 1
Crack 1 1
No Audible Alarm 1 1
Bent 1 1
Loss of or Failure to Bond 1 1
Use of Device Problem 1 1
Smoking 1 1
Migration or Expulsion of Device 1 1
Component Missing 1 1
Failure to Align 1 1
Arcing 1 1
Defective Device 1 1
Malposition of Device 1 1
Battery Problem 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Physical Resistance/Sticking 1 1
No Apparent Adverse Event 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 356 1404
No Patient Involvement 188 670
No Known Impact Or Consequence To Patient 84 86
Insufficient Information 38 55
Injury 17 17
Pain 17 24
Muscle/Tendon Damage 9 25
No Consequences Or Impact To Patient 9 21
Laceration(s) 8 8
Fall 7 11
Electric Shock 6 12
Bruise/Contusion 5 20
Bone Fracture(s) 2 2
Shock 2 4
No Code Available 1 1
Physical Entrapment 1 1
Muscle Spasm(s) 1 1
Unspecified Musculoskeletal problem 1 4
Concussion 1 1
Fatigue 1 1
No Information 1 1
Discomfort 1 5
Head Injury 1 1
Sprain 1 1
Neck Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Medical Div. of Stryker Corporation II Aug-09-2010
2 Stryker Medical Division of Stryker Corporation II Jun-01-2020
3 Stryker Medical Division of Stryker Corporation II Mar-17-2016
4 Stryker Medical Division of Stryker Corporation II Aug-03-2011
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