CARDINAL HEALTH SBAHFHPSPERecalls & reported problems
Cardinal Health 200, LLC · STERILE HERNIA PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488731780), received between Jun 19, 2019 and Jun 19, 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
Device problems
- Patient-Device Incompatibility1
Patient problems
- Itching Sensation1
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2019Patient-Device Incompatibility
THE CUSTOMER REPORTED THAT A PATIENT DEVELOPED A RED RASH AND SEVERE ITCHING ON THE ABDOMEN FROM THE ADHESIVE ON THE MINOR PROCEDURE DRAPE (B)(4) FROM THE HERNIA PACK (B)(4). THE PROCEDURE PERFORMED WAS A HERNIA REPAIR. DEXAMETHASONE CREAM WAS PRESCRIBED AND AN OVER THE COUNTER ANTIHISTAMINE. THE PATIENT IS NOW DOING WELL WITH ONLY MILD RESIDUAL REDNESS.
Patient problems: Itching Sensation; Rash
MAUDE report 8712870 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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