Telfa 1238Recalls & reported problems
Cardinal Health, Inc. · Non-adherent Pad Prepack · Class 1
- 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 10884521065307), received between May 26, 2020 and May 26, 2020 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THE PATIENT HAD CRANIOTOMY SURGERY AND A RETAINED SPONGE WAS NOTED IN THE MRI POST SURGERY. DISCLOSURE TO THE PATIENT/ PARENTS WAS DONE. PER NEUROSURGERY PROGRESS NOTES, IN REVIEWING THE PATIENT¿S POSTOP MRI, THERE WAS A NOTABLE T2 HYPERINTENSITY IN THE INTERHEMISPHERIC FISSURE POSTERIORLY WHICH WAS NOT NOTED ON THE PATIENT¿S PREOPERATIVE MRI. THERE WAS A CONCERN FOR RETAINED FOREIGN OBJECT, SPECIFICALLY TELFA USED FOR PROTECTION OF THE CEREBRAL CORTEX DURING THE DISSECTION OF THE INTERHEMISPHERIC FISSURE. ALTHOUGH THE SURGICAL COUNTS WERE CORRECT AT THE END OF THE OPERATIVE PROCEDURE, THE TELFA WAS CUT INTO STRIPS AND THEN COUNTED. THE TELFA USED DOES NOT HAVE STRINGS ATTACHED TO FACILITATE COUNTING. IN REVIEWING WITH OTHER OPERATIVE PERSONNEL PRESENT DURING THE SURGERY, IT APPEARS THAT ONE PIECE OF COUNTED TELFA MAY HAVE BEEN CUT AGAIN AND THE COUNT NOT UPDATED. THIS MAY ACCOUNT FOR THE DISCREPANCY BETWEEN THE CORRECT SURGICAL COUNT AND THE APPARENT RETAINED TELFA VISUALIZED ON MRI. THE PATIENT WAS SCHEDULED TO GO BACK TO THE OPERATING ROOM FOR THE REMOVAL OF THE RETAINED TELFA (EXPLORATION OF LEFT FRONTAL CRANIOTOMY FOR REMOVAL OF RETAINED FOREIGN BODY
Patient problems: Foreign Body In Patient
MAUDE report 10086818 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.