RID 02100260/80011Recalls & reported problems
Oystershell Consumer Health, Inc · Super Max Lice Elimination Kit · Class 1
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 00810061048114), received between Feb 3, 2023 and Feb 3, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Caustic/Chemical Burns1
- Hair Loss1
- Localized Skin Lesion1
- Pain1
- Scar Tissue1
- Skin Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 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 59-YEAR-OLD FEMALE WHO USED RID SUPER MAX 4 IN 1 COMPLETE LICE ELIMINATION KIT. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED WHICH WAS INCORPORATED INTO THIS REPORT. MEDICAL HISTORY INCLUDED CHRONIC NECK PAIN, CHRONIC BACK PAIN, SEASONAL ALLERGIES, AN UNSPECIFIED DISABILITY. THE CONSUMER USED PRODUCTS TO BLEACH AND COLOR HER HAIR PRIOR TO THE USE OF RID SUPER MAX 4 IN 1. BETWEEN (B)(6) 2022 AND (B)(6) 2022, SHE ALSO USED NUMEROUS LICE TREATMENTS INCLUDING HOME REMEDIES, LICE SHAMPOOS, AND LICE TREATMENT SPRAYS INCLUDING THE USE OF A HOMEOPATHIC LICE TREATMENT SPRAY FOR AN EXTENDED PERIOD. SHE REPORTED TO STILL HAVE LICE. ON (B)(6) 2022, THE CONSUMER APPLIED RID SUPER MAX 4 IN 1 COMPLETE LICE ELIMINATION KIT TO HER HAIR FOR LICE. THE CONSUMER REPORTED THAT SHE HAD SEVERE CHEMICAL BURNS WHICH BURNT HOLES IN HER SCALP, THE RINSE BURNT HER FACE (SHE DID NOT APPLY ON HER FACE), SHE DEVELOPED AN INFECTION, AND HAD PERMANENT HAIR LOSS. ON 12-(B)(6) 2023, THE CONSUMER PROVIDED A DESCRIPTION OF THE EVENT; SHE REPORTED APPLYING THE RID SOLUTION TO HER HAIR FOR 10 MINUTES, RINSING ONCE WITH H
Patient problems: Caustic/Chemical Burns; Hair Loss; Localized Skin Lesion; Pain; Scar Tissue; Skin Infection
MAUDE report 16294032 ↗
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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