TIDI 9210A-100Recalls & reported problems
Tidi Products, LLC · Grab 'n Go Eye Shields · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00618125132683), received between Nov 13, 2020 and Feb 24, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Shielding Failure” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Shielding Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2025Shielding Failure; Shielding Failure
CUSTOMER REPORTING A COMPLAINT ON PRODUCT#: 9210A-100. CUSTOMER STATES RN ON (B)(6) 2025 WAS PROVIDING CARE TO PATIENT IN FULL PPE. THIS INCLUDED THE TIDI EYEWEAR LOT#: 4353T200. BODILY FLUIDS FROM THE PATIENT (STOOL) STILL MANAGED TO GET IN HER EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21453291 ↗MalfunctionNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE GLASSES FELL OFF AND INTO A WOUND DURING THE BEGINNING STAGE OF SUTURING A WOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10836737 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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