TPLC - Total Product Life Cycle

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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	177	177
Fracture	84	84
Break	15	15
Misfire	15	15
Failure to Fire	7	7
Patient-Device Incompatibility	4	4
Device Handling Problem	3	3
Insufficient Information	2	2
Therapeutic or Diagnostic Output Failure	2	2
Positioning Failure	2	2
Use of Device Problem	2	2
Material Twisted/Bent	2	2
Material Protrusion/Extrusion	2	2
Device Dislodged or Dislocated	2	2
Improper or Incorrect Procedure or Method	2	2
Activation, Positioning or Separation Problem	1	1
Compatibility Problem	1	1
Mechanical Problem	1	1
Malposition of Device	1	1
Crack	1	1
Defective Component	1	1
Failure to Cut	1	1
Delivered as Unsterile Product	1	1
Retraction Problem	1	1
Detachment of Device or Device Component	1	1
Activation Failure	1	1
Appropriate Term/Code Not Available	1	1
Unexpected Therapeutic Results	1	1
Calcified	1	1
Device Inoperable	1	1
Firing Problem	1	1
Deformation Due to Compressive Stress	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	79	79
Hematoma	51	51
No Known Impact Or Consequence To Patient	35	35
Hematuria	34	34
Urinary Tract Infection	31	31
Hemorrhage/Bleeding	20	20
Pain	19	19
Sepsis	16	16
Urinary Retention	14	14
Insufficient Information	11	11
Low Blood Pressure/ Hypotension	7	7
Death	7	7
No Consequences Or Impact To Patient	6	6
Renal Failure	6	6
Foreign Body In Patient	6	6
Unspecified Infection	4	4
Device Embedded In Tissue or Plaque	4	4
No Code Available	4	4
Bacterial Infection	3	3
Dysuria	3	3
Needle Stick/Puncture	3	3
Cardiac Arrest	3	3
Pulmonary Embolism	2	2
Unspecified Tissue Injury	2	2
Calcium Deposits/Calcification	2	2
Heart Failure/Congestive Heart Failure	2	2
No Patient Involvement	2	2
Incontinence	2	2
Blood Loss	2	2
Failure of Implant	2	2
Abdominal Pain	2	2
Syncope/Fainting	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Deposits	1	1
Edema	1	1
Electrolyte Imbalance	1	1
Abdominal Distention	1	1
Rash	1	1
Fever	1	1
Embolism/Embolus	1	1
Inflammation	1	1
No Information	1	1
Discomfort	1	1
Urinary Incontinence	1	1
Scar Tissue	1	1
Bradycardia	1	1
Hyponatremia	1	1
Drug Resistant Bacterial Infection	1	1
Sudden Cardiac Death	1	1
Gangrene	1	1