TPLC - Total Product Life Cycle

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Device	catheter, ureteral, gastro-urology
Product Code	EYB
Regulation Number	876.5130
Device Class	2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT	2
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	2
DORNIER MEDTECH AMERICA INC
	SUBSTANTIALLY EQUIVALENT	1
ENDO OPTIKS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PROMEPAL SAM
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	19	19
Break	15	15
Inflation Problem	9	9
Material Puncture/Hole	8	8
Incorrect Measurement	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Deflation Problem	6	6
Material Fragmentation	5	5
Device Contaminated During Manufacture or Shipping	5	5
Material Twisted/Bent	4	4
Leak/Splash	4	4
Component Missing	4	4
Material Separation	3	3
Device Markings/Labelling Problem	3	3
Inaccurate Flow Rate	3	3
Nonstandard Device	2	2
Device Operates Differently Than Expected	2	2
Failure to Cut	2	2
Device Damaged Prior to Use	2	2
Defective Component	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Deformation	2	2
Patient Device Interaction Problem	2	2
Contamination /Decontamination Problem	2	2
Material Split, Cut or Torn	1	1
Device Fell	1	1
Wrong Label	1	1
No Flow	1	1
Out-Of-Box Failure	1	1
Obstruction of Flow	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Difficult to Remove	1	1
Defective Device	1	1
Device Displays Incorrect Message	1	1
Patient-Device Incompatibility	1	1
Deformation Due to Compressive Stress	1	1
Device Damaged by Another Device	1	1
Device Sensing Problem	1	1
Difficult to Advance	1	1
No Device Output	1	1
Off-Label Use	1	1
Misassembled	1	1
Fracture	1	1
Difficult to Insert	1	1
Labelling, Instructions for Use or Training Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Failure To Adhere Or Bond	1	1
Detachment Of Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	34	34
No Known Impact Or Consequence To Patient	32	32
No Consequences Or Impact To Patient	29	29
No Patient Involvement	5	5
Foreign Body In Patient	4	4
Device Embedded In Tissue or Plaque	4	4
No Information	3	3
No Code Available	3	3
Laceration(s)	2	2
Pain	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Patient Problem/Medical Problem	1	1
Stenosis	1	1
Discomfort	1	1
Foreign body, removal of	1	1
Perforation	1	1
Rash	1	1
Dyspnea	1	1
Fever	1	1
Hypersensitivity/Allergic reaction	1	1
Low Blood Pressure/ Hypotension	1	1
Unspecified Infection	1	1
Renal Impairment	1	1
Kidney Infection	1	1
Blister	1	1
Insufficient Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Hobbs Medical, Inc.	II	Oct-07-2022