MESH

by Unknown

Women's HealthFDA 510kOn market since 2015
82
Low Risk

The MESH by Unknown has a safety score of 82 out of 100, placing it in the low-risk category. Based on FDA MAUDE data, there have been 37 adverse event reports since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #4 out of 79 devices in the Women's Health category.

Adverse Events

37

Total reports filed with FDA MAUDE

Death Reports

0

Death reports associated with device

Incident Rate

0

Per 10,000 units in use

Recalls

0

No recalls on record

Estimated Units in Use

0

Based on market data estimates

Category Ranking

#4 of 79

In Women's Health by safety score

How This Compares

Safety Score82/100
Category Average
70
This Device
82
Best in Category
83

Important Context

Adverse event reports reflect reported incidents, not confirmed device failures. Higher numbers may indicate greater device usage, better reporting systems, or increased awareness. This data should be one factor in your research — always consult your physician.