TPLC - Total Product Life Cycle

show TPLC since

Device	implantable transprostatic tissue retractor system
Definition	The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Product Code	PEW
Regulation Number	876.5530
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	173	173
Fracture	84	84
Misfire	15	15
Break	10	10
Failure to Fire	7	7
Patient-Device Incompatibility	4	4
Device Handling Problem	3	3
Material Protrusion/Extrusion	2	2
Therapeutic or Diagnostic Output Failure	2	2
Insufficient Information	2	2
Positioning Failure	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Calcified	1	1
Crack	1	1
Mechanical Problem	1	1
Delivered as Unsterile Product	1	1
Retraction Problem	1	1
Unexpected Therapeutic Results	1	1
Device Inoperable	1	1
Activation, Positioning or Separation Problem	1	1
Detachment of Device or Device Component	1	1
Compatibility Problem	1	1
Malposition of Device	1	1
Failure to Cut	1	1
Appropriate Term/Code Not Available	1	1
Material Twisted/Bent	1	1
Mechanical Jam	1	1
Activation Failure	1	1
Firing Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	74	74
Hematoma	50	50
No Known Impact Or Consequence To Patient	35	35
Hematuria	34	34
Urinary Tract Infection	31	31
Pain	19	19
Hemorrhage/Bleeding	18	18
Sepsis	16	16
Urinary Retention	13	13
Insufficient Information	11	11
Low Blood Pressure/ Hypotension	7	7
Death	7	7
Renal Failure	6	6
Foreign Body In Patient	6	6
No Consequences Or Impact To Patient	6	6
Device Embedded In Tissue or Plaque	4	4
No Code Available	4	4
Unspecified Infection	4	4
Bacterial Infection	3	3
Cardiac Arrest	3	3
Dysuria	3	3
Needle Stick/Puncture	3	3
Calcium Deposits/Calcification	2	2
No Patient Involvement	2	2
Blood Loss	2	2
Syncope/Fainting	2	2
Heart Failure/Congestive Heart Failure	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Pulmonary Embolism	2	2
Failure of Implant	2	2
Incontinence	2	2
Hypoxia	1	1
Hypersensitivity/Allergic reaction	1	1
High Blood Pressure/ Hypertension	1	1
Inflammation	1	1
Myocardial Infarction	1	1
Rash	1	1
Scar Tissue	1	1
Tachycardia	1	1
Syncope	1	1
Abdominal Pain	1	1
Stroke/CVA	1	1
Infarction, Cerebral	1	1
Erosion	1	1
Bradycardia	1	1
Bruise/Contusion	1	1
Deposits	1	1
Edema	1	1
Extravasation	1	1
Fever	1	1
Gangrene	1	1
Granuloma	1	1
Headache	1	1
Hyponatremia	1	1
Drug Resistant Bacterial Infection	1	1
Urinary Incontinence	1	1
Swelling/ Edema	1	1
Embolism/Embolus	1	1
Cancer	1	1
Abdominal Distention	1	1
Pseudoaneurysm	1	1
No Information	1	1
Electrolyte Imbalance	1	1
Sudden Cardiac Death	1	1
Stenosis	1	1
Urinary Frequency	1	1