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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tips and pads, cane, crutch and walker
Product CodeINP
Regulation Number 890.3790
Device Class 1

MDR Year MDR Reports MDR Events
2014 27 27
2015 10 10
2016 6 6
2018 1 1
2019 1 1
2020 1 1
2022 1 1
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 15 15
Sticking 11 11
Product Quality Problem 4 4
Device Operates Differently Than Expected 4 4
Naturally Worn 4 4
Crack 3 3
Detachment Of Device Component 3 3
Unstable 2 2
Collapse 2 2
Bent 2 2
Device Slipped 1 1
Split 1 1
Material Integrity Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Separation 1 1
Appropriate Term/Code Not Available 1 1
Deformation Due to Compressive Stress 1 1
Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 17 17
Fall 13 13
No Known Impact Or Consequence To Patient 11 11
Injury 4 4
No Information 3 3
Ambulation Difficulties 3 3
Head Injury 2 2
Pain 2 2
Damage to Ligament(s) 1 1
Cyst(s) 1 1
Bone Fracture(s) 1 1
Confusion/ Disorientation 1 1
Insufficient Information 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medical Depot Inc. II Jun-30-2016
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