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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
2021 54 313
2022 36 362
2023 41 393
2024 27 356
2025 54 531

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Positioning 96 1663
Protective Measures Problem 35 143
Difficult to Fold, Unfold or Collapse 32 54
Device Fell 26 51
Sharp Edges 21 45
Detachment of Device or Device Component 7 7
Mechanical Problem 6 6
Collapse 4 4
Unintended Movement 4 4
Device Tipped Over 3 3
Patient Device Interaction Problem 3 3
Patient-Device Incompatibility 1 1
Positioning Failure 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 193 1936
Insufficient Information 12 294
Pain 8 8
Bruise/Contusion 5 85
Muscle/Tendon Damage 4 4
Abrasion 3 2
Unspecified Musculoskeletal problem 2 194
Bone Fracture(s) 2 2
Discomfort 2 2
Erythema 1 1
Laceration(s) 1 1
Swelling/ Edema 1 1
Deformity/ Disfigurement 1 1

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