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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device topical approximation system
Product CodeMZR
Regulation Number 880.5240
Device Class 1

MDR Year MDR Reports MDR Events
2020 84 84
2021 1 1
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 77 77
Mechanical Problem 4 4
Contamination 3 3
Material Integrity Problem 2 2
Detachment of Device or Device Component 2 2
Mechanical Jam 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 53 53
Unspecified Infection 22 22
No Clinical Signs, Symptoms or Conditions 6 6
Dysuria 3 3
Fever 3 3
Post Operative Wound Infection 2 2
Abscess 2 2
Pain 2 2
Urinary Tract Infection 2 2
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 2 2
Injury 1 1

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