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

Catalog Number	1191530
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	02/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per clinical trial (b)(4): on (b)(6) 2021 the subject patient underwent an open primary laparotomy duodenal sleeve resection procedure.A bard/davol phasix mesh was trimmed and implanted in onlay fashion and was fixated using a bard/davol sorbafix fixation device.The patient was discharged to home on (b)(6) 2021.On (b)(6) 2022, the patient was diagnosed with ventral hernia.It was reported that patient to return in july for ct-scan to determine if patient has had recurrence of disease.If no recurrence, patient will undergo treatment for the hernia.This ae has been assessed per study clinician as not related to the study device and definitely related to the index procedure.The adverse event has been assessed per third party clinician as definitely related to the study device and definitely related to the index procedure.The adverse event has been assessed as not recovered/resolved, moderate severity and a serious adverse event (sae) but does not meet the definition of an unanticipated adverse device effect (uade).
Additional Manufacturer Narrative
As reported, patient was diagnosed with a ventral hernia recurrence post implant of the phasix mesh.The clinician has assessed the patient¿s postoperative course of ventral hernia recurrence as definitely related to the study device and definitely related to the index procedure.However, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions-for-use, supplied with the device, as a possible complication.Review of manufacturing records confirms product was manufactured to specification.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.Not returned - remains implanted.

• 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: 15821726
• Report Number: 1213643-2022-00749
• Device Sequence Number: 12300939
• Product Code: OOD
• UDI-Device Identifier: 00801741107610
• UDI-Public: (01)00801741107610
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/31/2022

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: 11/28/2021
• Device Catalogue Number: 1191530
• Device Lot Number: HUDX2670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 61 KG