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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device retractor, all types
Product CodeEIG
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2016 3 3
2018 1 1
2019 3 3
2020 1 1
2021 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 5 5
Break 3 3
Appropriate Term/Code Not Available 2 2
Failure to Clean Adequately 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 5 5
Pain 5 5
Ulcer 5 5
No Known Impact Or Consequence To Patient 3 3
Swelling/ Edema 3 3
No Code Available 2 2
Swelling 2 2
No Consequences Or Impact To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1
Burn(s) 1 1

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