MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PHASIX ST MESH; SURGICAL MESH

Catalog Number	1201015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Stenosis (2263)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-sep-2019) is considered to be a best estimate.This emdr represents the bard phasix st mesh (device 2).An additional supplemental emdr was submitted to represent the bard ventralex st (device 1).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.
Event or Problem Description
Per information provided: (b)(6) 2018 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of ventralex st mesh (device 1).Per op notes, "midline incision was made, a medium sized ventralex st mesh (device 1) was placed into the fascial edges." (b)(6) 2020 - patient was diagnosed with hiatal hernia and chronic gerd thereby underwent open repair with the implant of phasix st mesh (device 2).(note: no op notes were provided in mr).(b)(6) 2020 - patient was diagnosed with esophageal stenosis after fundoplication with dysphagia, epigastric pain and extensive adhesions thereby underwent laparoscopic repair.Per op notes, "lysis of adhesions of the omentum from the anterior abdominal wall to the old mesh.There were adhesions above the level of the hiatus fairly intense that were taken down.".

• Brand Name: PHASIX ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 22858497
• Report Number: 1213643-2025-00783
• Device Sequence Number: 15760738
• Product Code: OWT
• UDI-Device Identifier: 00801741095344
• UDI-Public: (01)00801741095344(17)210828(10)HUDW1431
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2021
• Device Catalogue Number: 1201015
• Device Lot Number: HUDW1431
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male