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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device footrest, wheelchair
Product CodeIMM
Regulation Number 890.3920
Device Class 1

MDR Year MDR Reports MDR Events
2014 13 13
2015 9 9
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12 12
Crack 3 3
Device Operates Differently Than Expected 3 3
Device Inoperable 2 2
Out-Of-Box Failure 2 2
Bent 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Mechanical Problem 1 1
Product Quality Problem 1 1
Device Slipped 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 7 7
No Information 3 3
Fall 2 2
Bone Fracture(s) 1 1
Laceration(s) 1 1
Discomfort 1 1

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