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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 2
COLOPLAST
  SUBSTANTIALLY EQUIVALENT - KIT 1
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2014 72 72
2015 42 42
2016 26 26
2017 16 16
2018 111 111
2019 406 406
2020 261 261
2021 213 213
2022 199 199
2023 28 28
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1021 1021
Adverse Event Without Identified Device or Use Problem 220 220
Mechanical Problem 41 41
Defective Device 22 22
Malposition of Device 20 20
Break 15 15
Device Operates Differently Than Expected 12 12
Material Split, Cut or Torn 9 9
Migration or Expulsion of Device 7 7
Premature Activation 7 7
Device Dislodged or Dislocated 4 4
Torn Material 4 4
Use of Device Problem 4 4
Material Frayed 3 3
Component Missing 3 3
Appropriate Term/Code Not Available 2 2
Unsealed Device Packaging 2 2
Difficult to Insert 2 2
Migration 2 2
Detachment of Device or Device Component 2 2
Device Contamination with Chemical or Other Material 2 2
Unexpected Therapeutic Results 2 2
Connection Problem 2 2
Fluid/Blood Leak 2 2
Device Inoperable 1 1
Material Rupture 1 1
Inflation Problem 1 1
Packaging Problem 1 1
Material Twisted/Bent 1 1
Improper or Incorrect Procedure or Method 1 1
Device Appears to Trigger Rejection 1 1
Device Or Device Fragments Location Unknown 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Missing Information 1 1
Shelf Life Exceeded 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient-Device Incompatibility 1 1
Device Damaged Prior to Use 1 1
Extrusion 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 487 487
Incontinence 361 361
No Clinical Signs, Symptoms or Conditions 208 208
Urinary Incontinence 178 178
Insufficient Information 56 56
Pain 52 52
No Consequences Or Impact To Patient 36 36
Urinary Retention 33 33
Erosion 30 30
Unspecified Infection 16 16
Injury 16 16
Perforation 8 8
No Code Available 8 8
No Information 7 7
Urinary Tract Infection 7 7
Death 6 6
Emotional Changes 5 5
Hematoma 5 5
Complaint, Ill-Defined 5 5
Wound Dehiscence 5 5
Discomfort 5 5
Internal Organ Perforation 4 4
Failure of Implant 4 4
Foreign Body In Patient 4 4
Discharge 4 4
Hematuria 3 3
Fistula 3 3
Micturition Urgency 3 3
Abscess 3 3
Sepsis 2 2
Disability 2 2
Scarring 2 2
Blood Loss 2 2
Hemorrhage/Bleeding 2 2
Foreign Body Reaction 2 2
Numbness 2 2
Tissue Damage 2 2
Device Embedded In Tissue or Plaque 2 2
Impaired Healing 2 2
Scar Tissue 2 2
Prolapse 2 2
Fibrosis 1 1
Hypoesthesia 1 1
Urinary Frequency 1 1
Bacterial Infection 1 1
Pulmonary Embolism 1 1
Therapeutic Response, Decreased 1 1
Distress 1 1
Swelling/ Edema 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Medical Systems, Inc. II Dec-16-2014
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