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 Code	Hernia (2240)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per the clinical trial (b)(4): on (b)(6) 2021 the subject patient underwent right-hand assist laparoscopic radical nephrectomy, open repair during which a phasix mesh was trimmed, placed in onlay fashion, and fixated using sorbafix fasteners.Midline fascia and skin closure was achieved using sutures.The patient was discharged from the hospital on (b)(6) 2021.From (b)(6) 2021 to (b)(6) 2023 patient had multiple follow-up visits.On (b)(6) 2022, an incisional hernia was noted.At this time, the incisional hernia was assessed per clinician as not related to the study device.A previous mri ((b)(6) 2022) was reassessed; there was no evidence of a hernia.During a further visit on (b)(6) 2023, the patient was reexamined, and it was determined by physical examination that a hernia was present, with different presentation from the last visit on (b)(6) 2022.The incisional hernia has been assessed per clinician as mild in severity, definitely related to the study device and the procedure and not recovered/resolved.The reported ae meets the definition of a sae (serious adverse event) and does not meet the definition of uade (unanticipated adverse device event).
Additional Manufacturer Narrative
As reported, post implant of phasix mesh the patient developed an incisional hernia.The clinician has assessed the incisional hernia as definitely related to the study device and the procedure.However, based on the information provided, no conclusion can be made regarding the degree to which the phasix mesh may have caused or contributed to the incisional hernia.Review of manufacturing records confirms product was manufactured to specification.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed as a possible complication in the adverse reaction section of the instructions-for-use supplied with 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 - 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: 17511827
• Report Number: 1213643-2023-00289
• Device Sequence Number: 20217919
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2023

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: 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: 07/23/2023
• Initial Report FDA Received Date: 08/11/2023
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 155 KG