TPLC - Total Product Life Cycle

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Device	instrument, manual, general obstetric-gynecologic
Regulation Description	Obstetric-gynecologic general manual instrument.
Product Code	KOH
Regulation Number	884.4520
Device Class	1

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