TPLC - Total Product Life Cycle

show TPLC since

Device	bag, drainage, with adhesive, ostomy
Product Code	FON
Regulation Number	876.5900
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	5	5
Material Disintegration	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Sharp Edges	4	4
Failure To Adhere Or Bond	3	3
Improper or Incorrect Procedure or Method	3	3
Obstruction of Flow	3	3
Contamination /Decontamination Problem	2	2
Partial Blockage	2	2
Material Protrusion/Extrusion	2	2
Device Handling Problem	2	2
Positioning Problem	1	1
Complete Blockage	1	1
Fluid/Blood Leak	1	1
Melted	1	1
Difficult to Remove	1	1
Material Too Rigid or Stiff	1	1
Use of Device Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Gas/Air Leak	1	1
Device Contaminated During Manufacture or Shipping	1	1
Defective Device	1	1
Tear, Rip or Hole in Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	7	7
No Clinical Signs, Symptoms or Conditions	7	7
Skin Inflammation/ Irritation	5	5
Pain	5	5
Rash	3	3
Swelling/ Edema	2	2
Hemorrhage/Bleeding	2	2
Hypersensitivity/Allergic reaction	2	2
Itching Sensation	2	2
Skin Discoloration	2	2
Tissue Damage	1	1
Fungal Infection	1	1
Obstruction/Occlusion	1	1
Skin Inflammation	1	1
Tissue Breakdown	1	1
Foreign Body In Patient	1	1
Pneumothorax	1	1
Insufficient Information	1	1
Erythema	1	1
Respiratory Distress	1	1
Skin Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ConvaTec, Inc	II	Mar-21-2024