HALYARD ENT PACK IV
Received May 27, 2026 · Event occurred Apr 29, 2026
Report 3005997949-2026-00009 · MDR key 25303016
Device
Generic name
Surgical Drapes And Packs
Manufacturer
O&m Halyard, Inc.Model number
77823Catalog number
77823
Lot number
AC2532801D
Product problems
- Adhesive Too Strong
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE ADHESIVE STRIP SURROUNDING THE FENESTRATED DRAPE OPENING REMAINED ADHERED TO THE PROTECTIVE BACKING. THE ASSISTANT EXPERIENCED DIFFICULTY REMOVING IT, RESULTING IN TEARING OF THE ADHESIVE STRIP DURING REMOVAL. THE DRAPE WAS NO LONGER FUNCTIONAL IN THAT IT COULD NOT BE ADHERED TO THE SURGICAL SITE. THE USER CONTINUED TO UTILIZE FOR REMAINDER OF PROCEDURE. THERE WAS NO PATIENT HARM ACCORDING TO REPORTER.
Additional Manufacturer Narrative
THE PRODUCT INVOLVED IN THIS COMPLAINT IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.