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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device mesh, surgical, for stress urinary incontinence, male
Definition surgical treatment of male stress urinary incontinence post-prostatectomy
Product CodeOTM
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST
  SUBSTANTIALLY EQUIVALENT - KIT 1

MDR Year MDR Reports MDR Events
2019 406 406
2020 261 261
2021 213 213
2022 199 199
2023 28 28
2024 7 7

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
Use of Device Problem 3 3
Component Missing 3 3
Device Dislodged or Dislocated 3 3
Material Frayed 2 2
Connection Problem 2 2
Fluid/Blood Leak 2 2
Device Contamination with Chemical or Other Material 2 2
Unsealed Device Packaging 2 2
Device Contaminated During Manufacture or Shipping 1 1
Detachment of Device or Device Component 1 1
Packaging Problem 1 1
Difficult to Insert 1 1
Device Damaged Prior to Use 1 1
Appropriate Term/Code Not Available 1 1
Therapeutic or Diagnostic Output Failure 1 1
Migration 1 1
Device Appears to Trigger Rejection 1 1
Improper or Incorrect Procedure or Method 1 1
Missing Information 1 1
Material Twisted/Bent 1 1
Inflation Problem 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

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