TPLC - Total Product Life Cycle

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Device	instrument, surgical, disposable
Product Code	KDC
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	23	23
Material Separation	15	15
Adverse Event Without Identified Device or Use Problem	9	9
Unsealed Device Packaging	3	3
Defective Component	3	3
Delivered as Unsterile Product	2	2
Contamination	2	2
Insufficient Information	2	2
Appropriate Term/Code Not Available	1	1
Migration	1	1
Packaging Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Use of Device Problem	1	1
Crack	1	1
Defective Device	1	1
Patient-Device Incompatibility	1	1
Connection Problem	1	1
Device Markings/Labelling Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Manufacturing, Packaging or Shipping Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	35	35
No Known Impact Or Consequence To Patient	7	7
No Consequences Or Impact To Patient	6	6
Pain	5	5
Hemorrhage/Bleeding	3	3
Obstruction/Occlusion	3	3
Post Operative Wound Infection	2	2
Blood Loss	2	2
Not Applicable	2	2
Injury	2	2
Foreign Body In Patient	2	2
Insufficient Information	2	2
Failure of Implant	2	2
Bacterial Infection	2	2
Fistula	2	2
Hematoma	1	1
Failure to Anastomose	1	1
Abscess	1	1
Erosion	1	1
Calcium Deposits/Calcification	1	1
Purulent Discharge	1	1
Edema	1	1
Incontinence	1	1
Unspecified Infection	1	1
Laceration(s)	1	1
Menstrual Irregularities	1	1
Perforation	1	1
Pocket Erosion	1	1
Urinary Tract Infection	1	1
Perforation of Vessels	1	1
Gastrointestinal Hemorrhage	1	1
Unspecified Tissue Injury	1	1
No Patient Involvement	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024
2	Medical Action Industries, Inc. 306	II	Dec-22-2022
3	Medical Action Industries, Inc. 306	II	Jun-24-2021