TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
COLOPLAST CORP.
	SUBSTANTIALLY EQUIVALENT - KIT	2
COOK INCORPORATED
	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
Burst Container or Vessel	63	63
Adverse Event Without Identified Device or Use Problem	62	62
Break	28	28
Fracture	21	21
Fluid/Blood Leak	18	20
Material Deformation	15	15
Material Rupture	15	15
Material Separation	13	13
Inflation Problem	13	13
Material Split, Cut or Torn	12	12
Physical Resistance/Sticking	12	12
Device Contamination with Chemical or Other Material	10	10
Detachment of Device or Device Component	10	10
Difficult to Advance	10	10
Nonstandard Device	9	9
Material Fragmentation	9	9
Material Puncture/Hole	7	7
Difficult to Remove	7	7
Material Twisted/Bent	5	5
Device Contaminated During Manufacture or Shipping	4	4
Defective Device	4	4
Material Integrity Problem	4	4
Entrapment of Device	3	3
Appropriate Term/Code Not Available	3	3
Device Dislodged or Dislocated	3	3
Unsealed Device Packaging	3	3
Difficult to Insert	3	3
Mechanical Jam	2	2
Deformation Due to Compressive Stress	2	2
Tear, Rip or Hole in Device Packaging	2	2
Product Quality Problem	2	2
Device Handling Problem	2	2
Use of Device Problem	2	2
Positioning Failure	2	2
Separation Failure	2	2
Complete Blockage	2	2
Peeled/Delaminated	2	2
Crack	2	2
Difficult to Open or Remove Packaging Material	2	2
Leak/Splash	2	2
Unraveled Material	1	1
Fail-Safe Problem	1	1
Degraded	1	1
Inadequate Instructions for Healthcare Professional	1	1
Component Missing	1	1
Obstruction of Flow	1	1
Gas/Air Leak	1	2
Deflation Problem	1	2
Decrease in Pressure	1	1
Contamination	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	218	220
No Consequences Or Impact To Patient	32	32
No Known Impact Or Consequence To Patient	22	22
Insufficient Information	19	21
Sepsis	17	17
Hemorrhage/Bleeding	16	16
Obstruction/Occlusion	11	11
Foreign Body In Patient	9	9
Discomfort	7	7
Renal Failure	7	7
Urinary Tract Infection	6	6
No Code Available	5	5
Hematuria	5	5
Septic Shock	5	5
Pain	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Perforation	4	4
Unspecified Kidney or Urinary Problem	4	4
Hematoma	3	3
Pseudoaneurysm	3	3
Respiratory Failure	2	2
Pneumothorax	2	2
Failure of Implant	2	2
Post Operative Wound Infection	2	2
Fever	2	2
Pleural Effusion	2	2
Abscess	2	2
Pneumonia	2	2
Fistula	1	1
Pulmonary Embolism	1	1
Internal Organ Perforation	1	1
Hemothorax	1	1
Respiratory Insufficiency	1	1
Unspecified Tissue Injury	1	1
Anxiety	1	1
Perforation of Vessels	1	1
Fluid Discharge	1	2
No Patient Involvement	1	1
Urinary Retention	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	Cook Inc.	II	Oct-14-2020
4	Cook Inc.	II	Feb-04-2020