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

Catalog Number	1191025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Impaired Healing (2378)
Date of Event	04/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, about 11 months post-implant of the phasix mesh, the patient was diagnosed with wound dehiscence and mesh exposure.As reported the ae has not recovered/not resolved.The clinician has assessed the patient¿s postoperative course as being ¿definitely¿ related to the study device and procedure, however, based on the information provided, no conclusion can be made.Wound dehiscence is a known inherent risk of surgery and is listed in the instructions-for-use supplied with the device as a possible complication.Review of manufacturing records confirms product was manufactured to specification.Not returned - remains implanted.
Event or Problem Description
As reported per prevent clinical trial dvl-he-018: (b)(6).The subject patient underwent a primary laparotomy procedure to perform a choleyeystocolonic fistula takedown, in which the bard/davol phasix mesh was placed in onlay fashion.The phasix mesh was not trimmed to size, with the appropriate overlap in all directions beyond the margins of the fascial incision.Mechanical fixation (bard/davol sorbafix) was used to fixate the mesh.The midline fascia was completely closed with non-bard/davol, 1pds slow absorbing monofilament sutures in a running stitch technique.Skin closure was achieved using long-term absorbable sutures.(b)(6) 2021, the subject patient was discharged from the hospital.(b)(6) 2022, the patient experienced a wound complication with exposure of the phasix mesh."wound in the distal area is approx.4cm in size in original incision, scabbed over, but patient states scab falls off and re-scabs.Mesh is slightly exposed.Wound in proximal area approx.3cm, no mesh." the reported adverse event has been assessed per clinician as definitely related to the study device and definitely related to the procedure.As reported, the outcome of the adverse event not recovered/not resolved.The severity is reported to be mild with no action taken.

• Brand Name: PHASIX 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: 14513674
• Report Number: 1213643-2022-00345
• Device Sequence Number: 17533788
• Product Code: OOD
• UDI-Device Identifier: 00801741107580
• UDI-Public: (01)00801741107580
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Study,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2022

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: 08/28/2022
• Device Catalogue Number: 1191025
• Device Lot Number: HUEV1630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2020
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 107 KG