AquaGuard 50005-CSERecalls & reported problems
Tidi Products, LLC · TIDI Moisture Barrier Clear Polyethylene 98 per Case · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618125190331), received between Nov 22, 2024 and Nov 22, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024-LK UNT-2024-028693 CO-SUSPECT MEDICATION UNSPECIFIED DRESSING WAS UPDATED TO HYDRO SEAL DRESSING. ADDITIONAL CO-SUSPECT INCLUDED: UNSPECIFIED SOAP WIPE (ETHANOL, SOFT SOAP). IT WAS REPORTED THAT THE PATIENT HAD A TERRIBLE RASH AROUND THE OUTSIDE OF THE CENTRAL LINE DRESSING, WHERE HYDRO SEAL 5X5 BORDERS WERE PRESENT. THE RASH WAS PRESENT AT THE HYDRO SEAL BORDERS BENEATH AND TO HER FLANK AND DOWN TOWARD HER RIGHT SIDE TO WHERE PANT WAIST PRESENT (PREVIOUSLY REPORTED DERMATITIS CONTACT). SHE TRIED A SOAP WIPE AT THOSE SAME LOCATIONS AND THOUGHT THAT THIS MIGHT HAVE BEEN CAUSED BY THAT PRODUCT AS WELL, AS SHE WAS UNABLE TO WASH OFF THAT RESIDUE. SHE WENT TO AN URGENT CARE CLINIC RECENTLY, AND THEY [IN HOSPITAL] TOLD HER IT WAS DUE TO HYDRO SEAL. SHE USED STEROID CREAM [UNSPECIFIED] AND TRIED DIFFERENT TAPES TO SECURE THE HYDRO SEAL DRESSING.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 20761258 ↗
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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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