TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT - KIT	2
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT - KIT	4
	SUBSTANTIALLY EQUIVALENT	4
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	1
JBW7 INNOVATIONS, LLC
	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	81	81
Adverse Event Without Identified Device or Use Problem	64	64
Material Rupture	59	59
Fluid/Blood Leak	45	45
Break	38	38
Leak/Splash	34	34
Difficult to Remove	25	25
Material Separation	21	21
Fracture	20	20
Device Contamination with Chemical or Other Material	17	17
Detachment of Device or Device Component	16	16
Material Deformation	14	14
Difficult to Advance	13	13
Inflation Problem	13	13
Material Split, Cut or Torn	12	12
Material Puncture/Hole	11	11
Appropriate Term/Code Not Available	9	9
Material Fragmentation	9	9
Torn Material	7	7
Use of Device Problem	7	7
Material Integrity Problem	6	6
Obstruction of Flow	6	6
Nonstandard Device	5	5
Device Operates Differently Than Expected	5	5
Fitting Problem	5	5
Material Twisted/Bent	5	5
Connection Problem	4	4
Device Dislodged or Dislocated	4	4
Detachment Of Device Component	4	4
Defective Device	4	4
Deflation Problem	4	4
Difficult to Insert	4	4
Stretched	4	4
Crack	3	3
Entrapment of Device	3	3
Device Contaminated During Manufacture or Shipping	3	3
Deformation Due to Compressive Stress	2	2
Mechanical Jam	2	2
Tear, Rip or Hole in Device Packaging	2	2
Product Quality Problem	2	2
Device Handling Problem	2	2
Hole In Material	2	2
Device Packaging Compromised	2	2
Component Missing	2	2
Positioning Failure	2	2
Unsealed Device Packaging	2	2
Separation Failure	2	2
Kinked	2	2
Complete Blockage	2	2
Physical Resistance/Sticking	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	160	160
No Consequences Or Impact To Patient	137	137
No Known Impact Or Consequence To Patient	85	85
No Code Available	58	58
Hemorrhage/Bleeding	21	21
Foreign Body In Patient	14	14
Sepsis	13	13
No Patient Involvement	12	12
Insufficient Information	11	11
No Information	10	10
Obstruction/Occlusion	10	10
Renal Failure	8	8
Urinary Tract Infection	6	6
Perforation	6	6
Tissue Damage	6	6
Septic Shock	5	5
Device Embedded In Tissue or Plaque	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hematuria	4	4
Pain	4	4
Unspecified Infection	3	3
Blood Loss	3	3
Pseudoaneurysm	3	3
Abscess	3	3
Fistula	2	2
Pneumothorax	2	2
Failure of Implant	2	2
Respiratory Failure	2	2
Hematoma	2	2
Internal Organ Perforation	2	2
Post Operative Wound Infection	2	2
Fever	2	2
Pleural Effusion	2	2
Pneumonia	2	2
Pulmonary Embolism	1	1
Hemothorax	1	1
Respiratory Insufficiency	1	1
Embolism	1	1
Unspecified Tissue Injury	1	1
Anxiety	1	1
Perforation of Vessels	1	1
Fluid Discharge	1	1
Unspecified Kidney or Urinary Problem	1	1
Urinary Retention	1	1
Transient Ischemic Attack	1	1
Deposits	1	1
Cardiac Arrest	1	1
Purulent Discharge	1	1
Bowel Perforation	1	1
Urinary Incontinence	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Jul-09-2013
2	C.R. Bard, Inc.	II	Nov-04-2016
3	Cook Inc.	II	Dec-22-2021
4	Cook Inc.	II	Oct-14-2020
5	Cook Inc.	II	Feb-04-2020
6	Cook Inc.	II	Mar-24-2016