CVS Health 935683Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00050428307274), received between Oct 1, 2024 and Feb 11, 2026 — classified as 3 injuries.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  ON THE INITIAL REPORT DATED DECEMBER 12, 2025, THE CONSUMER STATED THAT HIS WIFE HAD A SKIN REACTION TO THE PRODUCT. ON THE COMPLETED CUSTOMER INFORMATION REQUEST (CIR) RECEIVED FROM THE CONSUMER ON JANUARY 19, 2026, THE CONSUMER REPORTED THAT AFTER COVERING AN ABRASION WITH PADS FOR THREE NIGHTS, AN ITCHY RASH DEVELOPED AT THE SITE OF PAD CONTACT. THE CONSUMER STATED THAT TREATMENT WAS REQUIRED. DUOBRII LOTION 0.01%/0.045% WAS APPLIED AS PRESCRIBED BY HER PHYSICIAN, AS WELL AS OTC CORTIZONE CREAM UNTIL THE RASH RESOLVED. THE CONSUMER ALSO CONFIRMED THAT THE SYMPTOMS STOPPED AFTER USING THE PRODUCT.

  Patient problems: Rash

  MAUDE report 24316475 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE INITIAL REPORT DATED 01/21/2025, THE CONSUMER STATED THAT THE PRODUCT STUCK TO HER WOUND AND TORE HER SKIN, CAUSING HER TO BLEED. ON THE COMPLETED CIR RECEIVED FROM THE CONSUMER ON 02/24/2025, SHE MENTIONED HAVING A WOUND ON HER ARM. CONSUMER STATED THAT TREATMENT WAS REQUIRED. THE DOCTOR RECOMMENDED COVERING THE WOUND WITH A NON-STICK PAD. HOWEVER, UPON CHANGING THE PAD, IT TORE HER SKIN OFF. THE CONSUMER CONSULTED THE DOCTOR AGAIN AND WAS PRESCRIBED ANTIBIOTIC CREAM AND ORAL MEDICATION. CONSUMER CONFIRMED THAT SYMPTOMS CORRECTED AFTER STOPPING USING THE PRODUCT.

  Patient problems: Rupture

  MAUDE report 21527935 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE INITIAL REPORT ON (B)(6) 2024, THE CONSUMER STATED THAT SHE USED THE PRODUCT ON A CUT ON HER ARMS. SHE WENT TO THE DOCTOR ON JULY 04. THEY WASHED THE PAD WITH STERILE WATER, AS THE PAD WAS STUCK TO THE WOUND, CAUSING IT TO BLEED. THE DOCTOR RECOMMENDED NOT USING THE PRODUCT AGAIN. ON THE COMPLETED CIR RECEIVED FROM THE CONSUMER ON (B)(6) 2024, THE CONSUMER STATED THAT THE PRODUCT WAS STUCK TO HER INJURY. SHE REQUIRED TREATMENT FROM A DOCTOR BECAUSE THE PRODUCT KEPT STICKING TO THE INJURY AND CAUSED BLEEDING WHEN SHE TRIED TO TAKE IT OFF.

  Patient problems: Rupture

  MAUDE report 20346382 ↗