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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 7 85

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Positioning 80 1264
Difficult to Fold, Unfold or Collapse 37 68
Protective Measures Problem 32 97
Device Fell 27 42
Sharp Edges 11 18
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
Material Twisted/Bent 1 1
Patient-Device Incompatibility 1 1
Mechanics Altered 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Break 1 1
Positioning Failure 1 1
Mechanical Problem 1 1
Device Slipped 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 131 1237
No Patient Involvement 43 310
Pain 12 12
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
No Consequences Or Impact To Patient 2 4
Discomfort 2 2
Injury 2 2
Deformity/ Disfigurement 1 1
No Information 1 1
Muscle Weakness 1 3
Spinal Column Injury 1 1
Vomiting 1 1
Asthma 1 1
Erythema 1 1
Bone Fracture(s) 1 1

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