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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
Regulation Description Hand-carried stretcher.
Product CodeFPP
Regulation Number 880.6900
Device Class 1

MDR Year MDR Reports MDR Events
2020 31 218
2021 54 313
2022 36 362
2023 41 393
2024 27 356
2025 15 118

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Positioning 89 1484
Protective Measures Problem 38 148
Difficult to Fold, Unfold or Collapse 33 61
Device Fell 26 38
Sharp Edges 16 30
Device Tipped Over 9 9
Collapse 4 4
Unintended Movement 4 4
Patient Device Interaction Problem 3 3
Fail-Safe Problem 2 2
Positioning Failure 2 2
Detachment of Device or Device Component 2 2
Mechanical Problem 1 1
Patient-Device Incompatibility 1 1
Premature Separation 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 162 1622
No Patient Involvement 16 144
Insufficient Information 13 187
Pain 13 13
Muscle/Tendon Damage 5 5
Bruise/Contusion 5 5
Abrasion 3 2
Bone Fracture(s) 2 2
Discomfort 2 2
Laceration(s) 2 2
No Information 1 1
Muscle Weakness 1 3
Asthma 1 1
Spinal Column Injury 1 1
Erythema 1 1
Vomiting 1 1
Swelling/ Edema 1 1
No Consequences Or Impact To Patient 1 1
Deformity/ Disfigurement 1 1

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