CARDINAL HEALTH SOP40SASBCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887488532561), received between Oct 20, 2017 and Oct 20, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 reports).

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.

• InjuryOct 20, 2017Patient-Device Incompatibility

  THIS ACCOUNT IS HAVING ISSUES WITH PACK SOP40SASBC LOT #449418 AND THE U-DRAPE 8476. BASED ON THE CUSTOMER INFORMATION SUBMITTED, THE PATIENT DEVELOPED A RASH FROM THE DRAPE AFTER SURGERY. THE PATIENT WAS TREATED WITH BACITRACIN AND A 4X4 TO RASH AREA.

  Patient problems: Rash

  MAUDE report 6966301 ↗
• InjuryOct 20, 2017Patient-Device Incompatibility

  THIS ACCOUNT IS HAVING ISSUES WITH PACK SOP40SASBC LOT #449418 AND THE U-DRAPE 8476. BASED ON THE CUSTOMER INFORMATION SUBMITTED, THE PATIENT DEVELOPED A RASH FROM THE DRAPE AFTER SURGERY AND WAS TREATED WITH BACITRACIN AND A 4X4.

  Patient problems: Rash

  MAUDE report 6966295 ↗
• InjuryOct 20, 2017Patient-Device Incompatibility

  THIS ACCOUNT IS HAVING ISSUES WITH PACK SOP40SASBC LOT #449418 AND THE U-DRAPE 8476. THE PATIENTS ARE GETTING A RASH ON SHOULDERS. DATE OF EVENT: (B)(6) 2021.

  Patient problems: Rash

  MAUDE report 6965984 ↗