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	Seroma (2069)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient was diagnosed with a seroma post implant of the phasix mesh.The clinician has assessed the patient¿s postoperative course of seroma as possibility related to the study device and definitely related to the index procedure.However, based on the information provided, no conclusion can be made.Seroma is a known inherent risk of 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.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in november 2021.Device not returned - remains implanted.
Event or Problem Description
As reported per clinical trial (b)(4): on (b)(6) 2023 the subject patient underwent primary laparotomy-colectomy procedure during which a phasix mesh was trimmed and placed in onlay fashion using sorbafix fixation device.The patient was discharged to home on (b)(6) 2023.On (b)(6) 2023, the patient was diagnosed with a seroma.The adverse event of seroma has been assessed per clinician as moderate in severity, possibly related to the study device, definitely related to the procedure, and recovering/resolving.No action has been taken.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)(6).On (b)(6) 2023 the subject patient underwent primary laparotomy-colectomy procedure during which a phasix mesh was trimmed and placed in onlay fashion using sorbafix fixation device.The patient was discharged to home on (b)(6) 2023.On (b)(6) 2023 the patient was diagnosed with a seroma.The adverse event of seroma has been assessed per clinician as moderate in severity, definitely related to the study device, definitely related to the procedure, and recovering/resolving.No action has been taken.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).
Additional Manufacturer Narrative
As reported, the patient was diagnosed with a seroma post implant of the phasix mesh.The clinician has assessed the patient¿s postoperative course of seroma as possibility related to the study device and definitely related to the index procedure.However, based on the information provided, no conclusion can be made.Seroma is a known inherent risk of 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.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in november 2021.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to correct the describe event or problem and manufacturer narrative.The clinician has assessed the patient¿s postoperative course of seroma 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.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: 16544758
• Report Number: 1213643-2023-00088
• Device Sequence Number: 5993769
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Study,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: 08/28/2023
• Device Catalogue Number: 1191530
• Device Lot Number: HUFW0401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/01/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2021
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 123 KG