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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
2018 154 154
2019 33 174
2020 31 218
2021 54 313
2022 36 362
2023 40 391

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Positioning 76 1185
Break 41 41
Difficult to Fold, Unfold or Collapse 37 68
Device Operates Differently Than Expected 32 32
Protective Measures Problem 31 92
Device Fell 27 42
Component Missing 27 35
Mechanical Problem 26 26
Sharp Edges 10 17
Crack 9 9
Device Tipped Over 9 9
Unintended System Motion 8 8
Structural Problem 6 39
Naturally Worn 5 5
Device Inoperable 5 5
Loose or Intermittent Connection 4 4
Collapse 4 4
Bent 4 4
Mechanical Jam 4 6
Sticking 4 4
Detachment of Device or Device Component 4 4
Appropriate Term/Code Not Available 4 4
Unintended Movement 3 3
Failure to Align 3 3
Detachment Of Device Component 3 3
Device Slipped 3 3
Connection Problem 2 2
Fail-Safe Problem 2 2
Mechanics Altered 2 2
Physical Resistance/Sticking 2 2
Insufficient Information 1 1
Premature Separation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Positioning Problem 1 1
Material Twisted/Bent 1 1
Activation, Positioning or Separation Problem 1 1
Patient-Device Incompatibility 1 1
Failure to Advance 1 1
Defective Component 1 1
Failure to Fold 1 1
Component Falling 1 1
Loss of or Failure to Bond 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 125 1152
No Known Impact Or Consequence To Patient 106 106
No Patient Involvement 49 316
No Consequences Or Impact To Patient 38 40
Pain 12 12
Insufficient Information 9 98
Bruise/Contusion 6 6
Injury 6 6
Muscle/Tendon Damage 5 5
Laceration(s) 4 4
Abrasion 3 2
No Information 2 2
Discomfort 2 2
Deformity/ Disfigurement 1 1
No Code Available 1 1
Asthma 1 1
Fall 1 1
Bone Fracture(s) 1 1
Muscle Weakness 1 3
Spinal Column Injury 1 1
Vomiting 1 1

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