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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stretcher, wheeled
Regulation Description Wheeled stretcher.
Product CodeFPO
Regulation Number 880.6910
Device Class 2

MDR Year MDR Reports MDR Events
2021 874 2467
2022 694 2688
2023 1028 3615
2024 956 4282
2025 916 3975
2026 303 979

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 724 2788
Unintended Movement 681 681
Mechanical Problem 572 1180
Device Fell 398 684
Difficult or Delayed Positioning 361 3952
Positioning Failure 351 1689
Fluid/Blood Leak 325 2999
Sharp Edges 282 1062
Device Slipped 202 675
Device Tipped Over 143 196
Difficult to Remove 139 386
Protective Measures Problem 119 302
Device Dislodged or Dislocated 103 237
Electrical /Electronic Property Problem 88 664
Grounding Malfunction 68 293
Patient Device Interaction Problem 59 63
Unstable 58 85
Detachment of Device or Device Component 43 43
Adverse Event Without Identified Device or Use Problem 39 39
Positioning Problem 30 30
Break 26 26
Insufficient Information 22 22
No Apparent Adverse Event 20 20
Collapse 13 13
Material Split, Cut or Torn 12 12
Fire 11 11
Patient-Device Incompatibility 10 11
No Audible Alarm 9 13
Use of Device Problem 8 8
Loose or Intermittent Connection 7 7
Physical Resistance/Sticking 7 7
Fail-Safe Did Not Operate 7 7
Battery Problem 7 7
Defective Device 6 6
Material Integrity Problem 6 7
Mechanics Altered 6 6
Communication or Transmission Problem 5 5
Corroded 5 5
Defective Component 5 5
Material Deformation 5 5
Intermittent Loss of Power 4 4
Component Missing 4 4
Therapeutic or Diagnostic Output Failure 4 4
Output Problem 4 4
Fail-Safe Problem 3 3
Degraded 3 3
Material Separation 3 3
Power Problem 3 3
Appropriate Term/Code Not Available 3 3
Nonstandard Device 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4216 17446
Insufficient Information 326 551
Pain 106 361
Laceration(s) 59 243
Muscle/Tendon Damage 45 346
Fall 40 433
Abrasion 35 55
Bruise/Contusion 27 375
Bone Fracture(s) 23 23
Unspecified Musculoskeletal problem 13 115
Unspecified Tissue Injury 13 13
Hematoma 10 14
Head Injury 9 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Consequences Or Impact To Patient 5 5
Discomfort 5 129
Electric Shock 4 121
Skin Tears 4 12
Deformity/ Disfigurement 3 3
Headache 3 5
Swelling/ Edema 3 6
Limb Fracture 3 3
Numbness 3 5
Hemorrhage/Bleeding 2 2
Shock 2 78
Eye Injury 2 3
No Patient Involvement 2 2
Burn(s) 2 2
Cardiac Arrest 2 2
Crushing Injury 2 2
Muscle Weakness 2 4
Inflammation 2 2
Brain Injury 2 2
Hip Fracture 2 2
Uterine Perforation 2 2
Needle Stick/Puncture 1 1
Neck Pain 1 1
Injury 1 1
Strangulation 1 1
Hernia 1 1
Movement Disorder 1 1
Retinal Injury 1 1
Physical Entrapment 1 1
Dizziness 1 1
Skull Fracture 1 1
Respiratory Arrest 1 1
Anxiety 1 1
Nodule 1 1
Shock from Patient Lead(s) 1 1
Aneurysm 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ferno-Washington Inc II Oct-10-2025
2 Ferno-Washington Inc II Nov-04-2022
3 Linet Spol. S.r.o. II Mar-04-2023
4 Stryker Medical Division of Stryker Corporation II Jul-12-2023
5 Stryker Medical Division of Stryker Corporation II Mar-15-2023
6 Stryker Medical Division of Stryker Corporation II Dec-14-2022
7 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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