TPLC - Total Product Life Cycle

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Device	clamp, circumcision
Regulation Description	Obstetric-gynecologic specialized manual instrument.
Product Code	HFX
Regulation Number	884.4530
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Product Quality Problem	60	60
Insufficient Information	37	37
Appropriate Term/Code Not Available	27	27
Material Too Soft/Flexible	19	19
Scratched Material	10	10
Flaked	9	9
Fitting Problem	8	8
Loss of or Failure to Bond	6	6
Pressure Problem	6	6
Lack of Effect	6	6
Defective Device	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Sharp Edges	4	4
Contamination	4	4
Detachment of Device or Device Component	3	3
Positioning Failure	3	3
Material Integrity Problem	3	3
Mechanical Problem	3	3
Material Fragmentation	2	2
Material Discolored	2	2
Problem with Sterilization	2	2
Failure to Cut	2	2
Defective Component	2	2
Fracture	2	2
Difficult to Open or Close	2	2
Separation Problem	2	2
Loose or Intermittent Connection	2	2
Patient Device Interaction Problem	1	1
Contamination /Decontamination Problem	1	1
Use of Device Problem	1	1
Failure to Align	1	1
Excess Flow or Over-Infusion	1	1
Structural Problem	1	1
Mechanics Altered	1	1
Therapeutic or Diagnostic Output Failure	1	1
Positioning Problem	1	1
Unexpected Color	1	1
Failure to Obtain Sample	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Contamination with Chemical or Other Material	1	1
No Apparent Adverse Event	1	1
Device Dislodged or Dislocated	1	1
Failure to Cycle	1	1
Break	1	1
Improper or Incorrect Procedure or Method	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	130	130
Hemorrhage/Bleeding	58	58
Genital Bleeding	24	24
Insufficient Information	15	15
Injury	7	7
Laceration(s)	7	7
Skin Tears	4	4
No Known Impact Or Consequence To Patient	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Code Available	2	2
Swelling/ Edema	2	2
Unspecified Tissue Injury	2	2
Tissue Damage	2	2
Wound Dehiscence	1	1
Adhesion(s)	1	1
Hematoma	1	1
Abrasion	1	1
Foreign Body In Patient	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Oct-18-2024
2	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-29-2023
3	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-19-2023