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

Catalog Number	1192040
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per the clinical trial (b)(4): on (b)(6) 2023, the subject patient underwent an open exploratory relaparotomy-colostomy reversal procedure during which a phasix mesh was trimmed and implanted in onlay fashion using absorbable monofilament 2-0 pds sutures.A 3cm overlap in all directions was achieved.The subject patient was discharged from the hospital on (b)(6) 2023.On (b)(6) 2023, the patient was diagnosed with surgical site infection which required hospitalization.This adverse event has been assessed per clinician as possibly related to the study device and definitely related to the procedure.The adverse event has been assessed as recovering/resolving, moderate in severity and a sae (serious adverse event) but does not meet the definition of uade (unanticipated adverse device event).
Additional Manufacturer Narrative
As reported, post relaparotomy-colostomy reversal procedure with implant of phasix mesh the patient developed a surgical site infection.The clinician has assessed the patient¿s postoperative course of surgical site infection as possibly related to the study device and definitely related to the study procedure.Based on the information provided, no conclusion can be made.Review of the manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in january 2022.Infection is a known inherent risk of surgery and is listed in as a possible complication in the adverse reaction section of the instructions-for-use supplied with the device.Additionally, the warning section states, " 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 device".Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : not returned.

• 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: 17078415
• Report Number: 1213643-2023-00225
• Device Sequence Number: 12330475
• Product Code: OOD
• UDI-Device Identifier: 00801741107634
• UDI-Public: (01)00801741107634
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Study,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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: 09/28/2023
• Device Catalogue Number: 1192040
• Device Lot Number: HUFX0235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 135 KG