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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 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1017 1017
Adverse Event Without Identified Device or Use Problem 215 215
Mechanical Problem 39 39
Defective Device 22 22
Malposition of Device 19 19
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
Torn Material 4 4
Use of Device Problem 4 4
Device Dislodged or Dislocated 4 4
Component Missing 3 3
Material Frayed 3 3
Connection Problem 2 2
Appropriate Term/Code Not Available 2 2
Migration 2 2
Unexpected Therapeutic Results 2 2
Fluid/Blood Leak 2 2
Detachment of Device or Device Component 2 2
Difficult to Insert 2 2
Device Contamination with Chemical or Other Material 2 2
Unsealed Device Packaging 2 2
Device Contaminated During Manufacture or Shipping 1 1
Device Damaged Prior to Use 1 1
Material Rupture 1 1
Packaging Problem 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Shelf Life Exceeded 1 1
Device Or Device Fragments Location Unknown 1 1
Material Integrity Problem 1 1
Device Appears to Trigger Rejection 1 1
Improper or Incorrect Procedure or Method 1 1
Missing Information 1 1
Device Inoperable 1 1
Material Twisted/Bent 1 1
Inflation Problem 1 1
Patient-Device Incompatibility 1 1
Therapeutic or Diagnostic Output Failure 1 1
Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 487 487
Incontinence 360 360
No Clinical Signs, Symptoms or Conditions 205 205
Urinary Incontinence 169 169
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
No Code Available 8 8
Perforation 8 8
Urinary Tract Infection 7 7
No Information 7 7
Death 6 6
Emotional Changes 5 5
Hematoma 5 5
Wound Dehiscence 5 5
Discomfort 5 5
Complaint, Ill-Defined 5 5
Discharge 4 4
Foreign Body In Patient 4 4
Failure of Implant 4 4
Internal Organ Perforation 4 4
Micturition Urgency 3 3
Fistula 3 3
Abscess 3 3
Hematuria 3 3
Blood Loss 2 2
Device Embedded In Tissue or Plaque 2 2
Disability 2 2
Impaired Healing 2 2
Numbness 2 2
Prolapse 2 2
Foreign Body Reaction 2 2
Hemorrhage/Bleeding 2 2
Tissue Damage 2 2
Scar Tissue 2 2
Scarring 2 2
Sepsis 2 2
Thrombosis 1 1
Inflammation 1 1
Muscle Spasm(s) 1 1
Nerve Damage 1 1
Neurological Deficit/Dysfunction 1 1
Pneumonia 1 1
Perforation of Vessels 1 1
Burning Sensation 1 1
Tingling 1 1
Fever 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Bleeding 1 1
Pulmonary Embolism 1 1
Stroke/CVA 1 1
Shaking/Tremors 1 1
Collapse 1 1
Reaction 1 1
Hypoesthesia 1 1
Surgical procedure 1 1
Therapeutic Response, Decreased 1 1
Urinary Frequency 1 1
Distress 1 1
Other (for use when an appropriate patient code cannot be identified) 1 1
Fibrosis 1 1
Weight Changes 1 1
Nerve Proximity Nos (Not Otherwise Specified) 1 1
Dysuria 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

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