PHASIX MESH
Received Mar 20, 2026 · Event occurred Mar 2, 2026
Report 1213643-2026-00347 · MDR key 24653834
Device
Generic name
Surgical Mesh
Manufacturer
Davol Inc., Sub. C.r. Bard, Inc. -1213643Model number
NACatalog number
1190400
Lot number
HUJQ1830
Product problems
- Use of Device Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS REPORTED, DURING AN EXPLORATORY LAPAROSCOPIC SMALL BOWEL RESECTION AND VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2026 THE PATIENT WAS IMPLANTED WITH A PHASIX MESH THAT HAD A LABELED EXPIRATION DATE OF 28-FEB-2026. THERE WAS NO PATIENT INJURY, NO CHANGE IN MEDICAL TREATMENT, OR ANY MEDICAL/SURGICAL INTERVENTION DUE TO THE ISSUE. AS REPORTED, THE MESH REMAINS IMPLANTED IN THE PATIENT'S BODY.
Additional Manufacturer Narrative
AS REPORTED, A PHASIX MESH WAS IMPLANTED BEYOND LABELED EXPIRATION DATE. THE LABELING OF THIS PRODUCT INCLUDES THE EXPIRATION DATE AND IS FOUND ON MULTIPLE LAYERS OF THE PACKAGING. THIS EVENT IS CONFIRMED AS A USE RELATED ERROR, WITH NO MALFUNCTION OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY, CHANGE IN COURSE OF TREATMENT, OR ANY MEDICAL/SURGICAL INTERVENTION DUE TO THE ISSUE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF 143 UNITS RELEASED FOR DISTRIBUTION. NOTE: SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.