• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
Definition Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Product CodePAH
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 2
MPATHY MEDICAL DEVICES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROMEDON S.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 334 334
2015 274 274
2016 697 697
2017 127 127
2018 173 173
2019 297 297
2020 171 171
2021 318 318
2022 159 159
2023 154 154
2024 186 186

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1072 1072
Insufficient Information 624 624
Break 184 184
Material Erosion 182 182
Migration 160 160
Appropriate Term/Code Not Available 130 130
Migration or Expulsion of Device 88 88
Extrusion 68 68
Material Protrusion/Extrusion 52 52
Device Operates Differently Than Expected 48 48
Detachment of Device or Device Component 47 47
Positioning Failure 42 42
Device Dislodged or Dislocated 38 38
Patient-Device Incompatibility 38 38
Material Twisted/Bent 30 30
Positioning Problem 28 28
Device Appears to Trigger Rejection 27 27
Other (for use when an appropriate device code cannot be identified) 24 24
No Apparent Adverse Event 19 19
Detachment Of Device Component 18 18
Material Deformation 18 18
Malposition of Device 16 16
Bent 13 13
Defective Device 12 12
Material Split, Cut or Torn 12 12
Difficult to Advance 11 11
Material Fragmentation 11 11
Premature Activation 10 10
Fracture 9 9
Patient Device Interaction Problem 7 7
Loose or Intermittent Connection 7 7
Therapeutic or Diagnostic Output Failure 6 6
Torn Material 6 6
Missing Information 6 6
Material Separation 6 6
Improper or Incorrect Procedure or Method 5 5
Unexpected Therapeutic Results 5 5
Device Slipped 4 4
Unintended Movement 4 4
Material Frayed 4 4
Difficult To Position 4 4
Deformation Due to Compressive Stress 3 3
Difficult to Remove 3 3
Device Or Device Fragments Location Unknown 3 3
Leak/Splash 3 3
Difficult or Delayed Separation 3 3
Activation, Positioning or Separation Problem 2 2
Defective Component 2 2
Disconnection 2 2
Component Falling 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1245 1245
Erosion 716 716
Incontinence 578 578
Injury 427 427
Urinary Tract Infection 296 296
Urinary Retention 285 285
Unspecified Infection 276 276
No Code Available 226 226
Micturition Urgency 209 209
No Clinical Signs, Symptoms or Conditions 209 209
Dysuria 160 160
Dyspareunia 159 159
Urinary Frequency 151 151
Urinary Incontinence 150 150
Hemorrhage/Bleeding 132 132
No Information 127 127
Prolapse 126 126
Surgical procedure 103 103
Insufficient Information 101 101
Death 99 99
Discomfort 97 97
Abnormal Vaginal Discharge 96 96
Scar Tissue 96 96
Inflammation 91 91
Scarring 86 86
Abdominal Pain 85 85
No Consequences Or Impact To Patient 84 84
Emotional Changes 81 81
No Known Impact Or Consequence To Patient 80 80
Hematuria 78 78
Not Applicable 77 77
Blood Loss 66 66
Constipation 63 63
Other (for use when an appropriate patient code cannot be identified) 61 61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 56 56
Burning Sensation 48 48
Foreign Body Reaction 47 47
Complaint, Ill-Defined 47 47
Obstruction/Occlusion 41 41
Internal Organ Perforation 40 40
Perforation 39 39
Intermenstrual Bleeding 37 37
Bacterial Infection 34 34
Tissue Damage 33 33
Fistula 33 33
Foreign Body In Patient 31 31
Nerve Damage 31 31
Cramp(s) /Muscle Spasm(s) 30 30
Laceration(s) 29 29
Nausea 28 28

Recalls
Manufacturer Recall Class Date Posted
1 Astora II Nov-16-2015
-
-