TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ALLWIN MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT - KIT	3
	SUBSTANTIALLY EQUIVALENT	2
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	2
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT - KIT	1
DORNIER MEDTECH AMERICA INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCAMED SAM
	SUBSTANTIALLY EQUIVALENT	1
URETERAL STENT COMPANY
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	543	543
Material Fragmentation	421	421
Calcified	238	238
Adverse Event Without Identified Device or Use Problem	237	237
Material Split, Cut or Torn	156	156
Difficult to Remove	146	146
Migration	131	131
Material Deformation	126	126
Difficult to Advance	110	110
Material Separation	107	107
Patient Device Interaction Problem	102	102
Detachment of Device or Device Component	99	99
Biocompatibility	92	92
Deformation Due to Compressive Stress	92	92
Fracture	51	51
Wrong Label	49	49
Material Twisted/Bent	37	37
Device Dislodged or Dislocated	35	35
Obstruction of Flow	33	33
Use of Device Problem	31	31
Material Too Rigid or Stiff	31	31
Component Missing	30	30
Difficult to Insert	27	27
Partial Blockage	25	25
Unsealed Device Packaging	24	24
Off-Label Use	21	21
Improper or Incorrect Procedure or Method	21	21
Complete Blockage	19	19
Device Damaged Prior to Use	19	19
Crack	19	19
Material Integrity Problem	19	19
Tear, Rip or Hole in Device Packaging	18	18
Accessory Incompatible	18	18
Inadequate Instructions for Healthcare Professional	18	18
Entrapment of Device	18	18
Device Contaminated During Manufacture or Shipping	18	18
Device Contamination with Chemical or Other Material	15	15
Component Misassembled	14	14
Nonstandard Device	14	14
Incorrect Measurement	13	13
Packaging Problem	13	13
Appropriate Term/Code Not Available	12	12
Defective Device	12	12
Device Handling Problem	11	11
Unraveled Material	11	11
Inaccurate Flow Rate	10	10
Device-Device Incompatibility	10	10
Device Markings/Labelling Problem	9	9
Failure to Advance	9	9
Flaked	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1654	1654
No Consequences Or Impact To Patient	327	327
No Known Impact Or Consequence To Patient	160	160
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	151	151
Pain	142	142
No Patient Involvement	83	83
Insufficient Information	80	80
Foreign Body In Patient	79	79
Discomfort	59	59
Urinary Tract Infection	59	59
Hematuria	53	53
Unspecified Infection	50	50
No Code Available	42	42
Obstruction/Occlusion	34	34
Unspecified Kidney or Urinary Problem	30	30
Hemorrhage/Bleeding	24	24
Micturition Urgency	21	21
Dysuria	20	20
Swelling/ Edema	19	19
Calcium Deposits/Calcification	18	18
Sepsis	16	16
Fever	16	16
Device Embedded In Tissue or Plaque	16	16
Fistula	13	13
Urinary Incontinence	12	12
Abdominal Pain	12	12
Post Operative Wound Infection	11	11
Inflammation	10	10
Urinary Frequency	10	10
Urinary Retention	10	10
Patient Problem/Medical Problem	10	10
Failure of Implant	9	9
Vomiting	9	9
Perforation	8	8
Renal Failure	7	7
Incontinence	7	7
Internal Organ Perforation	5	5
Laceration(s)	5	5
Swelling	5	5
No Information	4	4
Skin Inflammation/ Irritation	4	4
Erosion	4	4
Bacterial Infection	4	4
Exposure to Body Fluids	4	4
Occlusion	3	3
Urethral Stenosis/Stricture	3	3
Tachycardia	3	3
Irritability	3	3
Irritation	3	3
Injury	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Dec-30-2020
2	Cook Inc.	II	Feb-05-2021
3	Cook Inc.	II	Sep-15-2020
4	Cook Inc.	II	Feb-04-2020
5	Hobbs Medical, Inc.	II	Oct-07-2022