CARDINAL HEALTH SMA7CCSGRKRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488533629), received between Sep 19, 2016 and Sep 19, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjurySep 19, 2016Patient-Device Incompatibility

  BASED ON THE INFORMATION REPORTED BY THE CUSTOMER, A PATIENT HAD AN ALLERGIC REACTION TO THE ADHESIVE CLEAR WINDOW ON THE DRAPE. ЅR THE INFORMATION RECEIVED THE PATIENT IS ALLERGIC TO TEGADERM. THE PATIENT WAS PRESCRIBED BENADRYL, ZINC OXIDE CREAM AND TRIAMCINOLONE 0.1%. PATIENT WAS DISCHARGED TO HOME POST-OP DAY THREE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 5959794 ↗