CARDINAL HEALTH 20104Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630140039716), received between Jul 20, 2018 and Jul 20, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• InjuryJul 20, 2018Improper or Incorrect Procedure or Method

  BASED ON THE CUSTOMERS REPORT SHE STATED SHE HAD A USED COLD PACK THAT SHE HAD RECEIVED FROM A PRIOR HOSPITAL VISIT AND RECENTLY PLACED IT IN THE FREEZER. REPORTEDLY ON (B)(6) 2018 SHE PLACED THE FROZEN COLD PACK ON HER RIGHT KNEE AND STATED LATER NOTED A PINK AREA ON HER SKIN THAT LOOKED LIKE A BAD SUN BURN. THE SKIN PEELED. SHE THEN LOOKED OVER THE COLD PACK AND NOTED IT DID STATE DO NOT FREEZE AND SHE ADMITTED SHE HAD NOT READ THE COLD PACK THOROUGHLY BEFORE USE. SHE DID NOT SEEK ANY MEDICAL TREATMENT.

  Patient problems: Peeling; Skin Inflammation

  MAUDE report 7706336 ↗