Freeze Away Max Plantar Wart Remover 90000384Recalls & reported problems
Scholl'S Wellness Company LLC · Cryogenic Wart remover for Plantar Warts · Class 2
Data updated Oct 18, 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 00888853003214), received between Oct 11, 2023 and Oct 11, 2023 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2023, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A FEMALE (AGE UNKNOWN). ON (B)(6) 2023, THE CONSUMER USED A DR. SCHOLL'S FREEZE AWAY MAX PLANTAR WART REMOVER ON A SMALL WART ON HER INNER LEFT ARM. APPROXIMATELY AN HOUR AFTER APPLICATION, SHE EXPERIENCED INTENSE PAIN, BURNING, AND SWELLING AT THE SITE. SHE TOOK IBUPROFEN AND USED COLD COMPRESSES. THE NEXT DAY HER SYMPTOMS WERE WORSE, AND SHE WENT TO AN EMERGENCY ROOM. SHE WAS DIAGNOSED WITH A 2ND DEGREE BURN WHICH WAS ABOUT THE SIZE OF A DIME. SHE WAS GIVEN A TETANUS SHOT, PAIN MEDICATION, INSTRUCTIONS ON STERILE DRESSING CHANGES EVERY 4 HOURS, AND WAS PRESCRIBED ORAL AND TOPICAL ANTIBIOTICS.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 17912907 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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