TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	3
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT - KIT	2
	SUBSTANTIALLY EQUIVALENT	1
ROCAMED SAM
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN TRIOUS MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
URETERAL STENT COMPANY
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	562	562
Material Fragmentation	511	511
Adverse Event Without Identified Device or Use Problem	282	282
Calcified	252	252
Material Split, Cut or Torn	163	163
Difficult to Advance	148	148
Migration	142	142
Difficult to Remove	140	140
Material Deformation	127	127
Deformation Due to Compressive Stress	118	118
Detachment of Device or Device Component	108	108
Patient Device Interaction Problem	104	104
Material Separation	99	99
Biocompatibility	92	92
Wrong Label	52	52
Fracture	51	51
Material Twisted/Bent	43	43
Material Too Rigid or Stiff	34	34
Device Dislodged or Dislocated	33	33
Use of Device Problem	29	29
Difficult to Insert	28	28
Component Missing	27	27
Partial Blockage	24	24
Unsealed Device Packaging	24	24
Improper or Incorrect Procedure or Method	22	22
Obstruction of Flow	22	22
Off-Label Use	22	22
Accessory Incompatible	21	21
Device Contaminated During Manufacture or Shipping	20	20
Entrapment of Device	20	20
Complete Blockage	20	20
Tear, Rip or Hole in Device Packaging	19	19
Device-Device Incompatibility	18	18
Material Integrity Problem	18	18
Inadequate Instructions for Healthcare Professional	17	17
Device Contamination with Chemical or Other Material	16	16
Component Misassembled	16	16
Nonstandard Device	15	15
Packaging Problem	14	14
Crack	14	14
Defective Device	13	13
Incorrect Measurement	11	11
Flaked	11	11
Device Handling Problem	11	11
Premature Separation	11	11
Peeled/Delaminated	10	10
Migration or Expulsion of Device	10	10
Inaccurate Flow Rate	10	10
Positioning Problem	9	9
Device Markings/Labelling Problem	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2014	2014
No Consequences Or Impact To Patient	189	189
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	177	177
Pain	142	142
Foreign Body In Patient	92	92
Insufficient Information	87	87
No Known Impact Or Consequence To Patient	83	83
Urinary Tract Infection	61	61
Discomfort	59	59
Hematuria	57	57
Unspecified Infection	51	51
No Patient Involvement	46	46
Obstruction/Occlusion	35	35
Unspecified Kidney or Urinary Problem	30	30
No Code Available	24	24
Hemorrhage/Bleeding	23	23
Micturition Urgency	23	23
Sepsis	22	22
Dysuria	20	20
Swelling/ Edema	19	19
Calcium Deposits/Calcification	18	18
Fever	15	15
Abdominal Pain	14	14
Urinary Incontinence	13	13
Fistula	12	12
Device Embedded In Tissue or Plaque	12	12
Post Operative Wound Infection	11	11
Urinary Frequency	11	11
Urinary Retention	10	10
Exposure to Body Fluids	9	9
Vomiting	9	9
Inflammation	8	8
Patient Problem/Medical Problem	8	8
Incontinence	7	7
Perforation	7	7
Laceration(s)	7	7
Renal Failure	6	6
Skin Inflammation/ Irritation	5	5
Erosion	4	4
Internal Organ Perforation	4	4
Hypersensitivity/Allergic reaction	4	4
Failure of Implant	4	4
Bacterial Infection	3	3
Irritability	3	3
Injury	3	3
Tachycardia	3	3
Urethral Stenosis/Stricture	3	3
Nausea	3	3
Irritation	3	3
Fungal Infection	2	2

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