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

Catalog Number	1202530
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Fistula (1862); Unspecified Infection (1930)
Date of Event	12/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, about 2 months post-implant of a phasix st mesh in a clean-contaminated site, the patient experienced abscess, fistula, underwent medical intervention and antibiotic treatment.To date, this is the only reported complaint for this manufacturing lot.Based on the information provided, no conclusions can be made.Infection and fistula formation are known inherent risks of surgery and are listed in the adverse reactions section of the instructions-for-use (ifu) supplied with the device, as possible complications.Additionally, the warnings section of the ifu states "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." and "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh." should additional information be provided, a supplemental mdr will be submitted.Device evaluated by mfr : not returned - remains implanted.
Event or Problem Description
As reported, the patient underwent an ostomy reversal on (b)(6) 2020 with implant of a phasix st mesh in an in underlay fashion.As reported, procedure was considered to be "clean-contaminated" and there was no significant amount of spillage (bowel) during the procedure.The patient was readmitted with fluid collection/abscess on (b)(6) 2020 with no clear sinus track at that time and was treated with multiple rounds of antibiotics.As reported, the patient had ir (interventional radiology) drains placed during (b)(6) 2021.It was reported that there was a sinus track to the bowel noted on (b)(6) 2021, during an ir (interventional radiology) drain check for the drain placed on (b)(6) 2021.

• 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: 12410559
• Report Number: 1213643-2021-20298
• Device Sequence Number: 3722691
• Product Code: OWT
• UDI-Device Identifier: 00801741095375
• UDI-Public: (01)00801741095375
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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 Expiration Date: 03/28/2022
• Device Catalogue Number: 1202530
• Device Lot Number: HUEU1643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/01/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 81