Flex Box of Flex Disc 8 ct.Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850037498154), received between Jan 26, 2023 and Jan 26, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA EMAIL TO REPORT A SUSPECTED SYSTEMIC ALLERGIC REACTION TO FLEX DISC. THE CUSTOMER INSERTED A FLEX DISC FOR THE VERY FIRST TIME AT APPROXIMATELY 2:15PM IN THE AFTERNOON. AT AROUND 6PM SHE DISCOVERED THAT SHE HAD HIVES ALL OVER HER BODY AND FELT HER THROAT "CLOSING UP", SO SHE TOOK BENADRYL AND WENT TO THE EMERGENCY ROOM. THE CUSTOMER NOTED THAT SHE HAS ECZEMA AND A HOST OF KNOWN ALLERGIES/SENSITIVITIES, INCLUDING TO STRAWBERRIES, HUMMUS, LATEX, AND SILICAS FOUND IN SOME COSMETIC PRODUCTS WHICH CAUSES SEVERE PAIN IF THEY COME IN CONTACT WITH HER SKIN. THE CUSTOMER ALSO NOTED SHE HAD A SEVERE ALLERGY TO CEPHALOSPORINS, AND STATED THAT SHE HAD ALSO PREVIOUSLY EXPERIENCED A STEVENS-JOHNSON SYNDROME REACTION AFTER RECEIVING A ROCEPHIN INJECTION WHICH CAUSED HER SKIN TO PEEL FROM HER SCALP TO HER SHOULDERS FOR MONTHS AFTERWARDS. THE CUSTOMER STATES THAT SHE REMOVED HER FLEX DISC AT THE HOSPITAL AT AROUND 7 PM. CUSTOMER ALLEGED THAT HER SYMPTOMS BEGAN TO IMPROVE WITHIN MINUTES AFTER REMOVAL, BUT STATED THIS COULD BE DUE TO THE BENADRYL SHE HAD ALREADY TAKEN. THE CUSTOMER ALSO STATES THAT SHE RECEIVED IV PEPCID AND IV STEROID

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16251211 ↗