TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
ALLWIN MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT - KIT	3
BRIGHTWATER MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT	5
	SUBSTANTIALLY EQUIVALENT - KIT	2
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT - KIT	4
	SUBSTANTIALLY EQUIVALENT	9
DORNIER MEDTECH AMERICA INC.
	SUBSTANTIALLY EQUIVALENT	1
PROMEPLA SAM
	SUBSTANTIALLY EQUIVALENT	1
Q UROLOGICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
ROCAMED SAM
	SUBSTANTIALLY EQUIVALENT	1
URETERAL STENT COMPANY
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	827	827
Material Fragmentation	430	430
Calcified	325	325
Adverse Event Without Identified Device or Use Problem	271	271
Difficult to Remove	250	250
Material Separation	165	165
Material Split, Cut or Torn	163	163
Material Deformation	142	142
Migration	139	139
Detachment of Device or Device Component	113	113
Difficult to Advance	111	111
Patient Device Interaction Problem	102	102
Biocompatibility	99	99
Deformation Due to Compressive Stress	95	95
Fracture	81	81
Device Damaged Prior to Use	64	64
Wrong Label	49	49
Migration or Expulsion of Device	41	41
Device Dislodged or Dislocated	39	39
Material Twisted/Bent	38	38
Obstruction of Flow	37	37
Knotted	37	37
Component Missing	35	35
Partial Blockage	35	35
Torn Material	33	33
Crack	33	33
Use of Device Problem	33	33
Material Too Rigid or Stiff	32	32
Detachment Of Device Component	32	32
Kinked	30	30
Difficult to Insert	30	30
Unsealed Device Packaging	29	29
Tear, Rip or Hole in Device Packaging	28	28
Material Integrity Problem	25	25
Entrapment of Device	23	23
Device Contamination with Chemical or Other Material	23	23
Off-Label Use	21	21
Improper or Incorrect Procedure or Method	21	21
Appropriate Term/Code Not Available	21	21
Complete Blockage	20	20
Split	20	20
Device Operates Differently Than Expected	20	20
Accessory Incompatible	19	19
Device Contaminated During Manufacture or Shipping	18	18
Out-Of-Box Failure	18	18
Inadequate Instructions for Healthcare Professional	18	18
Occlusion Within Device	17	17
Packaging Problem	16	16
Defective Device	16	16
Insufficient Information	14	14

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	656	656
No Known Impact Or Consequence To Patient	464	464
No Patient Involvement	190	190
Pain	185	185
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	151	151
No Code Available	131	131
Foreign Body In Patient	103	103
Insufficient Information	80	80
Discomfort	62	62
Hematuria	61	61
Unspecified Infection	60	60
Urinary Tract Infection	60	60
No Information	42	42
Obstruction/Occlusion	37	37
Device Embedded In Tissue or Plaque	33	33
Unspecified Kidney or Urinary Problem	30	30
Calcium Deposits/Calcification	26	26
Hemorrhage/Bleeding	25	25
Urinary Retention	24	24
Micturition Urgency	21	21
Dysuria	20	20
Fever	19	19
Swelling/ Edema	19	19
Sepsis	16	16
Abdominal Pain	15	15
Patient Problem/Medical Problem	14	14
Fistula	13	13
Surgical procedure, additional	13	13
Urinary Incontinence	12	12
Urinary Frequency	11	11
Failure of Implant	11	11
Post Operative Wound Infection	11	11
Foreign body, removal of	11	11
Vomiting	10	10
Inflammation	10	10
Perforation	10	10
Renal Failure	9	9
Occlusion	9	9
Swelling	8	8
Incontinence	7	7
Injury	7	7
Laceration(s)	6	6
Internal Organ Perforation	6	6
Erosion	5	5
Bacterial Infection	5	5
Death	5	5
Skin Inflammation/ Irritation	4	4
Exposure to Body Fluids	4	4
Hypersensitivity/Allergic reaction	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Dec-30-2020
2	Boston Scientific Corporation	II	May-21-2009
3	C.R. Bard, Inc.	II	Nov-14-2016
4	Cook Inc.	II	Feb-05-2021
5	Cook Inc.	II	Sep-15-2020
6	Cook Inc.	II	Feb-04-2020
7	Hobbs Medical, Inc.	II	Oct-07-2022
8	Vance Products Incorporated	II	Jun-25-2015
9	Vance Products Incorporated	II	Jan-05-2011
10	Vance Products Incorporated	II	Feb-10-2009
11	Vance Products Incorporated	II	Jan-23-2009