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	55	55
Appropriate Term/Code Not Available	35	35
Material Too Soft/Flexible	19	19
No Apparent Adverse Event	12	12
Scratched Material	10	10
Fitting Problem	9	9
Mechanical Problem	9	9
Flaked	9	9
Pressure Problem	7	7
Difficult to Open or Close	7	7
Loss of or Failure to Bond	6	6
Defective Device	6	6
Detachment of Device or Device Component	6	6
Lack of Effect	6	6
Sharp Edges	5	5
Loose or Intermittent Connection	4	4
Component Incompatible	4	4
Contamination	4	4
Failure to Align	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Failure to Seal	3	3
Material Integrity Problem	3	3
Problem with Sterilization	2	2
Use of Device Problem	2	2
Material Discolored	2	2
Material Fragmentation	2	2
Fracture	2	2
Device Dislodged or Dislocated	2	2
Therapeutic or Diagnostic Output Failure	2	2
Separation Problem	2	2
Mechanics Altered	1	1
Excess Flow or Over-Infusion	1	1
Unexpected Color	1	1
Inadequacy of Device Shape and/or Size	1	1
Patient Device Interaction Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Difficult to Remove	1	1
Missing Information	1	1
Failure to Cycle	1	1
Connection Problem	1	1
Failure to Obtain Sample	1	1
Unintended Movement	1	1
Separation Failure	1	1
Break	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	151	151
Hemorrhage/Bleeding	78	78
Genital Bleeding	48	48
Insufficient Information	15	15
Laceration(s)	9	9
Skin Tears	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Unspecified Tissue Injury	2	2
Swelling/ Edema	2	2
Wound Dehiscence	1	1
Emotional Changes	1	1
Adhesion(s)	1	1
Hematoma	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