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

Catalog Number	1190820
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient was diagnosed with abdominal pain post implant of the phasix mesh.The clinician has assessed the patient¿s postoperative course of abdominal pain as possibly related to the study device.However, based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.Pain is a known complication of surgery and is listed in the adverse reactions 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.
Event or Problem Description
As reported per clinical trial dvl-he-018: on (b)(6) 2021, the subject patient underwent robotic assisted laparoscopic, laparotomy, colectomy procedure in infraumbilical location.A phasix mesh was trimmed and placed in onlay fashion and fixated using absorbable monofilament sutures with 14 fixation points.The patient discharge from the hospital on (b)(6) 2021.From (b)(6) 2022 to (b)(6) 2023 patient experienced multiple adverse events and visited the hospital multiple times, all the adverse events reported during this period were not related to the study device.On (b)(6) 2023 the subject patient experienced abdominal pain.The adverse event of abdominal pain has been assessed per clinician as mild in severity, possibly related to the study device, possibly related to the procedure, and recovered/resolved.The reported adverse event does not meet the definition of an sae (serious adverse event) and does not meet the uade (unanticipated adverse device effect).
Event or Problem Description
As reported per clinical trial (b)(4): on (b)(6) 2021, the subject patient underwent robotic assisted laparoscopic, laparotomy, colectomy procedure in infraumbilical location.A phasix mesh was trimmed and placed in onlay fashion and fixated using absorbable monofilament sutures with 14 fixation points.The patient discharge from the hospital on (b)(6) 2021.From (b)(6) 2022 to (b)(6) 2023 patient experienced multiple adverse events and visited the hospital multiple times, all the adverse events reported during this period were not related to the study device.On (b)(6) 2023 the subject patient experienced abdominal pain.The adverse event of abdominal pain has been assessed per clinician as mild in severity, possibly related to the study device, possibly related to the procedure, and recovered/resolved.The reported adverse event does not meet the definition of an sae (serious adverse event) and does not meet the uade (unanticipated adverse device effect).Addendum: the reported adverse event (abdominal pain) has been re-assessed per clinician as not related to the study device.
Additional Manufacturer Narrative
As reported, the patient was diagnosed with abdominal pain post implant of the phasix mesh.The clinician has assessed the patient¿s postoperative course of abdominal pain as possibly related to the study device.However, based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.Pain is a known complication of surgery and is listed in the adverse reactions section of the instructions-for-use, supplied with the device.Addendum: this is an addendum to the initial mdr submitted to document that the ae was clinically re-evaluated as not related to the study 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.

• 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: 17238586
• Report Number: 1213643-2023-00251
• Device Sequence Number: 6969972
• Product Code: OOD
• UDI-Device Identifier: 00801741107566
• UDI-Public: (01)00801741107566(17)210528(10)HUDR1444
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 03/20/2025

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: 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: 06/13/2023
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 78 KG