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

Catalog Number	1200710
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the phasix st mesh was protruding through the patient's abdomen about 2 months post-implant.As reported, the surgeon "did not feel there was anything wrong with the mesh"; however, based on the information available, no conclusions can be made.Extrusion is a known inherent risk of surgery/use of the device and is listed as a possible complication in the adverse reactions section of the instructions-for-use supplied with the device.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 220 units released for distribution in november 2021.Note, the date of event is provided as an estimate based on the information provided.Not returned - remains implanted.
Event or Problem Description
As reported, the patient was implanted with a bard/davol phasix st mesh for a ventral hernia repair on (b)(6) 2022.As reported, about 2 months post-implant, the mesh was noted to be protruding from the abdomen.As reported, the surgeon "did not feel there is anything wrong with the phasix st mesh, just the patient's fascia".As reported, the surgeon decided to debride the wound and will continue to monitor the patient.

• Brand Name: PHASIX ST 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: 15340057
• Report Number: 1213643-2022-00613
• Device Sequence Number: 12517698
• Product Code: OWT
• UDI-Device Identifier: 00801741095337
• UDI-Public: (01)00801741095337
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2022

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: 07/28/2023
• Device Catalogue Number: 1200710
• Device Lot Number: HUFW0277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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 Sex: Unknown