TPLC - Total Product Life Cycle

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Device	tube, drainage, suprapubic
Regulation Description	Suprapubic urological catheter and accessories.
Product Code	FFA
Regulation Number	876.5090
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	21	21
Adverse Event Without Identified Device or Use Problem	17	17
Difficult to Remove	15	15
Detachment of Device or Device Component	15	15
Material Separation	12	12
Defective Device	11	11
Device Dislodged or Dislocated	9	9
Material Deformation	7	7
Deformation Due to Compressive Stress	7	7
Device-Device Incompatibility	5	5
Entrapment of Device	4	4
Difficult to Advance	4	4
Obstruction of Flow	4	4
Material Split, Cut or Torn	3	3
Material Twisted/Bent	3	3
Difficult to Insert	2	2
Use of Device Problem	2	2
Fracture	2	2
Fluid/Blood Leak	2	2
Leak/Splash	1	1
Device Contaminated During Manufacture or Shipping	1	1
Collapse	1	1
Unsealed Device Packaging	1	1
Positioning Problem	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	60	60
Pain	12	12
Foreign Body In Patient	10	10
Hemorrhage/Bleeding	8	8
Unspecified Infection	3	3
Fever	3	3
Abscess	2	2
Sepsis	2	2
Cellulitis	2	2
Rash	1	1
Urinary Tract Infection	1	1
Anxiety	1	1
Obstruction/Occlusion	1	1
Hematuria	1	1
Bowel Perforation	1	1
Device Embedded In Tissue or Plaque	1	1
Unspecified Kidney or Urinary Problem	1	1
Unspecified Tissue Injury	1	1
Insufficient Information	1	1
Bacterial Infection	1	1
Fistula	1	1
Pyrosis/Heartburn	1	1
Inflammation	1	1
Internal Organ Perforation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Sep-13-2024