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

Catalog Number	1201520
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	08/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post-implant of phasix st mesh, the patient underwent subsequent surgical intervention for lysis of adhesion and mesh removal.Based on the information available, no conclusions can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Adhesions is a known inherent risk of the device and is listed as a possible complications in the adverse reaction section of the instructions for use (ifu) supplied with the device.
Event or Problem Description
As reported, during an exploratory laparotomy procedure on (b)(6) 2021, the patient underwent drainage of fluid collection, removal of unspecified synthetic permanent mesh and a ventral hernia repair, during which a bard/davol phasix st mesh was implanted.As reported, the patient underwent a laparoscopic cholecystectomy, cholangiogram and lysis of adhesions on (b)(6) 2021.It was reported that the patient underwent another exploratory laparotomy procedure on (b)(6) 2022, during which some of the mesh was removed from an abdominal wound along with lysis of adhesions and small bowel strictureplasty.

• 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: 14885909
• Report Number: 1213643-2022-00484
• Device Sequence Number: 12059429
• Product Code: OWT
• UDI-Device Identifier: 00801741095351
• UDI-Public: (01)00801741095351
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2022

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 Catalogue Number: 1201520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 87 YR
• Patient Sex: Female