DermaCol Ag 00503ERecalls & reported problems
Sion Brands LLC · Class U
Data updated Oct 13, 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 00714196503442), received between Feb 19, 2025 and Feb 19, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Localized Skin Lesion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE COMPLAINANT USED THE DRESSING ALONG WITH OTHER WOUND CARE SUPPLIES THAT WERE PROVIDED BY MAIL FROM A MEDICAL SUPPLY COMPANY. THE PATIENT USED THE DRESSING IN CONJUNCTION WITH MEDIHONEY AND A ZINC OXIDE PASTE WRAP. HE CLAIMED TO HAVE USED 3-4 DRESSINGS, AND AT A ROUTINE DRESSING CHANGE "2 DAYS LATER" A WORSENING CONDITION OF THE WOUND WAS NOTED. THE PATIENT HAS REPORTED DAILY GRIEVOUS PAIN AND BODILY INJURY WITH USE OF THE PRODUCT; HOWEVER, NO IMAGES OR PHOTOS HAVE BEEN RECEIVED YET BY COVALON AFTER REPEATED ATTEMPTS AT CONTACT AND REQUESTS FOR ADDITIONAL INFORMATION.
Patient problems: Localized Skin Lesion
MAUDE report 21411175 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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