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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
Definition Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.
Product CodePAJ
Regulation Number 878.3300
Device Class 2

MDR Year MDR Reports MDR Events
2014 66 66
2015 286 286
2016 267 267
2017 96 96
2018 9 9
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 676 676
Insufficient Information 39 39
Device Operates Differently Than Expected 3 3
Device Packaging Compromised 2 2
Extrusion 1 1
Component Missing 1 1
Folded 1 1
Patient-Device Incompatibility 1 1
Positioning Problem 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 553 553
Pain 105 105
Injury 48 48
Erosion 32 32
Unspecified Infection 25 25
Urinary Retention 22 22
Urinary Tract Infection 14 14
Disability 9 9
Dysuria 4 4
No Known Impact Or Consequence To Patient 4 4
Scarring 4 4
Incontinence 4 4
Nerve Damage 3 3
Fistula 3 3
Internal Organ Perforation 2 2
Abdominal Pain 2 2
No Code Available 2 2
Constipation 2 2
Prolapse 2 2
Deformity/ Disfigurement 2 2
Scar Tissue 2 2
No Consequences Or Impact To Patient 2 2
Vaginal Mucosa Damage 1 1
Blood Loss 1 1
Swelling 1 1
Perforation 1 1
Hemorrhage/Bleeding 1 1
Death 1 1
Edema 1 1
Itching Sensation 1 1
Muscle Spasm(s) 1 1
Nausea 1 1

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