CARDINAL HEALTH SOP12SH10ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439610109), received between Dec 23, 2019 and Dec 23, 2019 — 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.

• InjuryDec 23, 2019Patient-Device Incompatibility

  BASED ON INFORMATION RECEIVED BY THE OPERATING ROOM DIRECTOR, THE PATIENT ALLEGEDLY SUFFERED A SEVERE BURN/REACTION WHICH LED TO A SKIN GRAFT. THE HOSPITAL WAS UNABLE TO DETERMINE WHICH DRAPE MAY HAVE ALLEGEDLY CAUSED THE BURN/REACTION.

  Patient problems: Caustic/Chemical Burns; No Code Available

  MAUDE report 9512291 ↗