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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
2019 33 174
2020 31 218
2021 54 313
2022 36 362
2023 41 393
2024 16 265

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Positioning 84 1414
Difficult to Fold, Unfold or Collapse 37 68
Protective Measures Problem 34 122
Device Fell 28 43
Sharp Edges 13 22
Device Tipped Over 10 10
Structural Problem 6 39
Component Missing 5 13
Collapse 4 4
Mechanical Jam 4 6
Unintended Movement 2 2
Patient Device Interaction Problem 2 2
Fail-Safe Problem 2 2
Device Slipped 1 1
Break 1 1
Mechanical Problem 1 1
Patient-Device Incompatibility 1 1
Positioning Failure 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 139 1416
No Patient Involvement 43 310
Pain 13 13
Insufficient Information 10 100
Muscle/Tendon Damage 5 5
Bruise/Contusion 5 5
Abrasion 3 2
Laceration(s) 3 3
No Known Impact Or Consequence To Patient 2 2
Injury 2 2
Discomfort 2 2
No Consequences Or Impact To Patient 2 4
No Information 1 1
Bone Fracture(s) 1 1
Muscle Weakness 1 3
Asthma 1 1
Spinal Column Injury 1 1
Erythema 1 1
Vomiting 1 1
Swelling/ Edema 1 1
Deformity/ Disfigurement 1 1

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