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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

MDR Year MDR Reports MDR Events
2019 6 6
2020 5 5
2021 3 3
2022 6 6
2023 8 8
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Misfire 8 8
Break 7 7
Detachment of Device or Device Component 6 6
Use of Device Problem 4 4
Physical Resistance/Sticking 2 2
Firing Problem 2 2
Failure to Advance 2 2
Retraction Problem 2 2
Activation, Positioning or Separation Problem 2 2
Material Twisted/Bent 1 1
Difficult to Advance 1 1
Failure to Fire 1 1
Defective Device 1 1
Difficult to Remove 1 1
Activation Failure 1 1
Device-Device Incompatibility 1 1
Activation Problem 1 1
Product Quality Problem 1 1
Entrapment of Device 1 1
Failure to Capture 1 1
Insufficient Information 1 1
Failure to Disconnect 1 1
Component Missing 1 1
Positioning Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
Insufficient Information 7 7
Foreign Body In Patient 5 5
No Known Impact Or Consequence To Patient 5 5
No Consequences Or Impact To Patient 3 3
Hemorrhage/Bleeding 2 2
Adhesion(s) 1 1
Hematoma 1 1
Paresthesia 1 1
Constipation 1 1
No Patient Involvement 1 1
Increased Sensitivity 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Urinary Tract Infection 1 1
Balance Problems 1 1
Prolapse 1 1
Muscle Weakness 1 1
Micturition Urgency 1 1
Device Embedded In Tissue or Plaque 1 1
Dysuria 1 1
Ambulation Difficulties 1 1
Bacterial Infection 1 1
Burning Sensation 1 1
Inflammation 1 1
Numbness 1 1
Urinary Retention 1 1
Scar Tissue 1 1
Dyspareunia 1 1
Depression 1 1
Fecal Incontinence 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jul-30-2024
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