inforMED
InjuryCBH

ANCHORFAST

Received Jul 2, 2026 · Event occurred Jun 29, 2026

Report 1119193-2026-00048 · MDR key 25693911

Device

Generic name

Oral Endotracheal Tube Fastener

Catalog number

9799

Lot number

5F212

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Unspecified Tissue Injury

Narrative

Description of Event or Problem

THIS IS THE 2ND OF TWO REPORTS FROM THE SAME ACCOUNT. IT WAS REPORTED THAT A PATIENT EXPERIENCED CHEEK AND UPPER LIP PRESSURE AND SKIN BREAKDOWN WHILE USING THE HOLLISTER ANCHORFAST ENDOTRACHEAL TUBE HOLDER. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT NEEDED DEBRIDEMENT, SUTURE REPAIR, AND RESUTURE REPAIR DUE TO DEHISCENCE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

DHR REVIEW COMPLETED AND WAS FOUND TO BE COMPLETE AND ACCURATE. THE DEVICE WAS NOT AVAILABLE FOR RETURN, SO DEVICE EXAMINATION WAS NOT POSSIBLE. THE ROOT CAUSE FOR THE REPORTED ISSUE IS NOT KNOWN.