TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
COLOPLAST CORP.
	SUBSTANTIALLY EQUIVALENT - KIT	1
SHENZHEN TRIOUS MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YOUCARE TECHNOLOGY CO.,LTD. (WUHAN)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	62	62
Burst Container or Vessel	49	49
Break	25	25
Fracture	19	19
Material Deformation	15	15
Nonstandard Device	14	14
Material Rupture	14	14
Fluid/Blood Leak	13	14
Physical Resistance/Sticking	13	13
Material Split, Cut or Torn	12	12
Difficult to Advance	12	12
Inflation Problem	11	11
Detachment of Device or Device Component	10	10
Material Separation	9	9
Device Contamination with Chemical or Other Material	8	8
Material Puncture/Hole	8	8
Material Fragmentation	6	6
Dull, Blunt	4	4
Loss of or Failure to Bond	4	4
Device Contaminated During Manufacture or Shipping	3	3
Separation Failure	3	3
Unsealed Device Packaging	3	3
Defective Device	3	3
Material Twisted/Bent	3	3
Material Too Soft/Flexible	2	2
Device Dislodged or Dislocated	2	2
Tear, Rip or Hole in Device Packaging	2	2
Product Quality Problem	2	2
Positioning Failure	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Difficult to Insert	2	2
Difficult to Remove	2	2
Contamination	2	2
Crack	2	2
Difficult to Open or Remove Packaging Material	2	2
Entrapment of Device	2	2
Unraveled Material	1	1
Component Missing	1	1
Obstruction of Flow	1	1
Gas/Air Leak	1	2
Inadequate Instructions for Healthcare Professional	1	1
Deflation Problem	1	2
Solder Joint Fracture	1	1
Device Handling Problem	1	1
Failure to Capture	1	1
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Fell	1	1
Peeled/Delaminated	1	1
Appropriate Device Problem Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	248	250
Insufficient Information	19	21
Sepsis	17	17
Hemorrhage/Blood Loss/Bleeding	15	15
Obstruction/Occlusion	11	11
Foreign Body In Patient	10	10
Renal Failure	7	7
Discomfort	7	7
Urinary Tract Infection	6	6
Hematuria	5	5
Perforation	5	5
Septic Shock	5	5
Pain	5	5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Unspecified Kidney or Urinary Problem	4	4
Hematoma	3	3
No Consequences Or Impact To Patient	3	3
Pseudoaneurysm	3	3
Pneumothorax	2	2
Failure of Implant	2	2
Respiratory Failure	2	2
Post Operative Wound Infection	2	2
Fever	2	2
Pleural Effusion	2	2
Pneumonia	2	2
Abscess	2	2
Fistula	1	1
Pulmonary Embolism	1	1
Hemothorax	1	1
Respiratory Insufficiency	1	1
Unspecified Tissue Injury	1	1
Anxiety	1	1
Fluid Discharge	1	2
Urinary Retention	1	1
Exposure to Body Fluids	1	1
Thrombosis/Thrombus	1	1
Transient Ischemic Attack	1	1
Deposits	1	1
Cellulitis	1	1
Cardiac Arrest	1	1
Purulent Discharge	1	1
Bowel Perforation	1	1
Urinary Incontinence	1	1
Liver Damage/Dysfunction	1	1
Unspecified Infection	1	1
Hypovolemic Shock	1	1
Abdominal Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Sep-05-2025
2	Cook Inc.	II	Dec-22-2021
3	Olympus Corporation of the Americas	II	Nov-20-2025