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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse
Definition Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair
Product CodePWI
Regulation Number 884.4910
Device Class 2


Premarket Reviews
ManufacturerDecision
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 4 4
2019 6 6
2020 5 5
2021 3 3
2022 6 6
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 8 8
Misfire 4 4
Detachment of Device or Device Component 3 3
Failure to Advance 2 2
Activation, Positioning or Separation Problem 2 2
Insufficient Information 2 2
Firing Problem 2 2
Physical Resistance/Sticking 2 2
Activation Problem 1 1
Appropriate Term/Code Not Available 1 1
Activation Failure 1 1
Difficult to Advance 1 1
Material Twisted/Bent 1 1
Failure to Disconnect 1 1
Defective Device 1 1
Failure to Fire 1 1
Failure to Capture 1 1
Entrapment of Device 1 1
Inadequate Instructions for Healthcare Professional 1 1
Migration or Expulsion of Device 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
Insufficient Information 6 6
No Clinical Signs, Symptoms or Conditions 6 6
Foreign Body In Patient 5 5
No Consequences Or Impact To Patient 3 3
Depression 1 1
Numbness 1 1
Prolapse 1 1
Ambulation Difficulties 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Dysuria 1 1
Adhesion(s) 1 1
Bacterial Infection 1 1
Micturition Urgency 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Muscle Weakness 1 1
Pain 1 1
Scar Tissue 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Burning Sensation 1 1
Device Embedded In Tissue or Plaque 1 1
Constipation 1 1
Balance Problems 1 1
Paresthesia 1 1
Dyspareunia 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Increased Sensitivity 1 1
Fecal Incontinence 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II May-04-2018
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