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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device table, cystometric, electric
Product CodeMMZ
Regulation Number 876.4890
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 3 3
Collapse 1 1
Positioning Problem 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sonesta Medical Ab II Apr-28-2017
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