CARDINAL HEALTH 103BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888499007409), received between Jul 9, 2018 and Jul 9, 2018 — classified as 1 injury.

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.

• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTS THAT SHE HAD SURGERY AT (B)(6) IN (B)(6) AND THAT THE HOSPITAL PROVIDED HER WITH FOUR CARDINAL HEALTH ICE PACKS. ON OR AROUND (B)(6) 2018 PATIENT STATES SHE SQUEEZED AND SHOOK THE 2 SHE HADN'T USED, ONE WAS CATALOG NUMBER 103B LOT V6B078 AND REPORTEDLY WRAPPED IT IN A TOWEL AND PLACED IT ON HER LOWER BACK. SHE REPORTS THAT SHE REPORTEDLY WOKE UP TO 2ND DEGREE THERMAL BURNS FROM THE COLD PACK(S). SHE REPORTS SHE HAS BEEN SEEN IN THE EMERGENCY ROOM (ER) ON 2 OCCASIONS AND WAS PROVIDED PAIN MEDICATION THROUGH AN IV (DILAUDID AND FENTANYL). SHE WAS PROVIDED A MEDICATION FOR NAUSEA. SHE WAS GIVEN ANTIBIOTIC OINTMENT TO ADMINISTER 3 TIMES A DAY AND WAS TOLD TO WASH AND WRAP THE WOUND. THERE WAS REDNESS AND BLISTERS ON HER LOWER BACK. SHE REPORTS THEY HAVE NOW SCABBED AND ARE PEELING.

  Patient problems: Burn, Thermal; Partial thickness (Second Degree) Burn

  MAUDE report 7671407 ↗