Cardea SOLO M300-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10857553006112), received between Dec 14, 2023 and Dec 14, 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 16, 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.

• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  PATIENT EXPERIENCED SEVERE RASH AND BLISTERING OF HER SKIN DURING WEAR OF THE M300 (SENSOR). THE PATIENT STARTED EXPERIENCING SOME ITCHING, BURNING AND DISCOMFORT AFTER WEARING THE PATCH FOR 1-2 DAYS. DUE TO DISCOMFORT, THE PATIENT REMOVED THE SENSOR AFTER WEARING IT FOR 4 DAYS AND 21 HOURS (B)(6) 2023). STAFF SAID SHE CAME TO THE CLINIC HOLDING A WET COMPRESS ON THE WOUND AND REQUESTED TO SPEAK WITH THE MEDICAL STAFF. SHE DESCRIBED THAT SHE HAD SOME DISCOMFORT AND REMOVED THE SENSOR EARLY DUE TO CONCERNS, WHEN SHE REMOVED THE PATCH THAT'S WHEN HER SKIN SHOWED THE BLISTERING AND THE RASH. PHYSICIAN INITIALLY SUGGESTED AT-HOME REMEDIES AND CARE. HOWEVER, AFTER A WEEK, THE AREA WASN'T HEALLING SO HE PROVIDED THE PATIENT WITH A TOPICAL STEROID CREAM AND IS MONITORING HER HEALING PROCESS. IT WAS REPORTED (B)(6) 2023 THE PATIENT DID WELL WITH THE TOPICAL STEROID CREAM. ALTHOUGH TEMPERATURES WERE ABOVE NORMAL DURING THE WEAR PERIOD, PATIENT REPORTED TO HAVE SPENT MOST OF THE WEAR PERIOD TIME INDOORS AND WAS NOT WORKING IN THE SUN OR DOING MANY OUTDOOR ACTIVITIES.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 18332737 ↗