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

Catalog Number	1190820
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Alleged per clinical study ((b)(4)): on (b)(6) 2021, the subject patient underwent primary laparoscopic colectomy procedure, during which a phasix mesh rectangle (8x20cm) was trimmed and placed in onlay fashion using pds suture.The patient was discharged to home on (b)(6) 2021.The subject patient was diagnosed with scar tissue formation and no action was taken.The ae is clinically assessed to be of mild severity, possibly related to the study device, possibly related to procedure and recovered/resolved with sequelae.The reported adverse event does not meet the uade (unanticipated adverse device effect).
Additional Manufacturer Narrative
As reported, a patient was diagnosed with a scar tissue formation post implant of the phasix mesh and resolved with no action taken.The clinician has assessed the patient¿s postoperative course of scar tissue formation as possibly related to the study device and possibly related to the procedure.However, based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.

• 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: 15554190
• Report Number: 1213643-2022-00644
• Device Sequence Number: 14971839
• Product Code: OOD
• UDI-Device Identifier: 00801741107566
• UDI-Public: (01)00801741107566
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: 1190820
• Device Lot Number: HUDR1444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2019
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 96 KG