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); Fistula (1862)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the phasix st mesh devices were implanted into a moderately contaminated site during an ostomy take down and ventral hernia repair procedure.The patient experienced bowel adhesions, and fistula formation and approximately eight months post-implant underwent subsequent surgical intervention to excise the mesh.The instructions-for-use (ifu) warns, ¿the use of any synthetic mesh or patch in a contaminated or infected wound could lead to fistula formation and/or extrusion of the mesh and it is not recommended¿.Additionally, adhesions and fistula formation are known inherent risks of surgery and are listed in the adverse reactions section of the ifu supplied with the device, as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Based on the information available, no conclusions can be made.This mdr represents the bard/davol phasix st mesh (device #1).An additional mdr was submitted to represent the bard/davol phasix st mesh (device #2).Note, the date of implant was estimated as (b)(6) 2020 based on the available information.Should additional information be provided, a supplemental mdr will be submitted.
Event or Problem Description
As reported, during (b)(6) 2020 the patient underwent surgery for an ostomy take down and ventral hernia repair procedure using two pieces of bard/davol phasix st mesh, one for the hernia (device #1), and one for the ostomy site (device #2).As reported, the surgical site was moderately contaminated.As reported on (b)(6) 2021, the patient underwent explant of mesh due to severe adhesions to bowel and fistula.

• 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
• MDR Report Key: 12286793
• Report Number: 1213643-2021-20234
• Device Sequence Number: 11714068
• Product Code: OWT
• UDI-Device Identifier: 00801741095344
• UDI-Public: (01)00801741095344
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2021

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 Catalogue Number: 1201015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention