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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

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Positioning 58 847
Break 41 41
Device Operates Differently Than Expected 32 32
Difficult to Fold, Unfold or Collapse 31 54
Component Missing 27 35
Mechanical Problem 26 26
Protective Measures Problem 25 72
Device Fell 21 31
Crack 9 9
Device Tipped Over 8 8
Unintended System Motion 8 8
Sharp Edges 7 10
Structural Problem 6 39
Naturally Worn 5 5
Device Inoperable 5 5
Sticking 4 4
Bent 4 4
Detachment of Device or Device Component 4 4
Appropriate Term/Code Not Available 4 4
Collapse 4 4
Loose or Intermittent Connection 4 4
Failure to Align 3 3
Device Slipped 3 3
Mechanical Jam 3 5
Detachment Of Device Component 3 3
Physical Resistance/Sticking 2 2
Connection Problem 2 2
Fail-Safe Problem 2 2
Mechanics Altered 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Positioning Problem 1 1
Component Falling 1 1
Failure to Fold 1 1
Loss of or Failure to Bond 1 1
Insufficient Information 1 1
Activation, Positioning or Separation Problem 1 1
Defective Component 1 1
Failure to Advance 1 1
Unintended Movement 1 1
Positioning Failure 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 106 106
No Clinical Signs, Symptoms or Conditions 89 765
No Patient Involvement 49 316
No Consequences Or Impact To Patient 38 40
Pain 11 11
Injury 6 6
Insufficient Information 6 6
Muscle/Tendon Damage 5 5
Bruise/Contusion 5 5
Laceration(s) 4 4
No Information 2 2
No Code Available 1 1
Bone Fracture(s) 1 1
Abrasion 1 1
Fall 1 1
Asthma 1 1
Vomiting 1 1
Muscle Weakness 1 3
Spinal Column Injury 1 1

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