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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 3 3
2022 5 5
2023 6 6
2024 11 11
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 24 24
Material Split, Cut or Torn 2 2
Defective Device 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Erosion 11 11
Insufficient Information 8 8
Pain 7 7
Urinary Incontinence 6 6
Abnormal Vaginal Discharge 6 6
Urinary Tract Infection 5 5
Hemorrhage/Bleeding 5 5
Prolapse 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Inflammation 4 4
Constipation 3 3
Adhesion(s) 3 3
Abscess 3 3
Micturition Urgency 3 3
Fistula 2 2
Urinary Frequency 2 2
Unspecified Kidney or Urinary Problem 2 2
Scar Tissue 2 2
Dyspareunia 2 2
Obstruction/Occlusion 2 2
Perforation 2 2
Dizziness 2 2
Abdominal Pain 2 2
Injury 1 1
Fever 1 1
Thrombosis/Thrombus 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Foreign Body In Patient 1 1
Incontinence 1 1
Purulent Discharge 1 1
Flatus 1 1
Urinary Retention 1 1
Hernia 1 1
Anemia 1 1
Malaise 1 1
Muscle Weakness 1 1
Hematoma 1 1
Tachycardia 1 1
Anxiety 1 1
Stenosis 1 1
Swelling/ Edema 1 1
Unspecified Tissue Injury 1 1
Unspecified Heart Problem 1 1
Nausea 1 1
Fatigue 1 1
Wound Dehiscence 1 1
Low Blood Pressure/ Hypotension 1 1
Internal Organ Perforation 1 1
Unspecified Infection 1 1

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