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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, manual, general obstetric-gynecologic
Regulation Description Obstetric-gynecologic general manual instrument.
Product CodeKOH
Regulation Number 884.4520
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2024 1 1
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Neuropathy 1 1
Urinary Incontinence 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Incontinence 1 1
Foreign Body In Patient 1 1
Micturition Urgency 1 1
Numbness 1 1
Erosion 1 1
Urinary Tract Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-23-2021
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