TPLC - Total Product Life Cycle

show TPLC since

Device	mesh, surgical, for stress urinary incontinence, male
Definition	surgical treatment of male stress urinary incontinence post-prostatectomy
Product Code	OTM
Regulation Number	878.3300
Device Class	2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST
	SUBSTANTIALLY EQUIVALENT - KIT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	898	898
Adverse Event Without Identified Device or Use Problem	116	116
Mechanical Problem	38	38
Defective Device	21	21
Break	13	13
Material Split, Cut or Torn	9	9
Premature Activation	7	7
Malposition of Device	7	7
Device Dislodged or Dislocated	3	3
Use of Device Problem	3	3
Component Missing	3	3
Device Contamination with Chemical or Other Material	2	2
Connection Problem	2	2
Unsealed Device Packaging	2	2
Fluid/Blood Leak	2	2
Material Frayed	2	2
Inflation Problem	1	1
Difficult to Insert	1	1
Device Appears to Trigger Rejection	1	1
Detachment of Device or Device Component	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Twisted/Bent	1	1
Improper or Incorrect Procedure or Method	1	1
Device Damaged Prior to Use	1	1
Packaging Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Missing Information	1	1
Appropriate Term/Code Not Available	1	1
Migration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	426	426
Incontinence	226	226
No Clinical Signs, Symptoms or Conditions	205	205
Urinary Incontinence	169	169
Insufficient Information	56	56
No Consequences Or Impact To Patient	34	34
Pain	25	25
Urinary Retention	13	13
Unspecified Infection	8	8
Erosion	8	8
Wound Dehiscence	5	5
Hematoma	5	5
No Code Available	5	5
Urinary Tract Infection	4	4
Perforation	4	4
Complaint, Ill-Defined	3	3
Injury	2	2
Device Embedded In Tissue or Plaque	2	2
Impaired Healing	2	2
Hematuria	2	2
Hemorrhage/Bleeding	2	2
Scar Tissue	2	2
Foreign Body Reaction	2	2
Micturition Urgency	2	2
Stroke/CVA	1	1
Emotional Changes	1	1
Pulmonary Embolism	1	1
Abscess	1	1
Bacterial Infection	1	1
Sepsis	1	1
Thrombosis	1	1
Tissue Damage	1	1
Nerve Damage	1	1
Nerve Proximity Nos (Not Otherwise Specified)	1	1
Foreign Body In Patient	1	1
No Information	1	1
Discomfort	1	1
Hypoesthesia	1	1
Disability	1	1
Pneumonia	1	1
Perforation of Vessels	1	1
Skin Inflammation/ Irritation	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1