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

Catalog Number	1190300
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Necrosis (1971); Seroma (2069)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, it is alleged that post implant of the phasix mesh, the patient had seroma, infection, necrosis and underwent subsequent surgical intervention for mesh explant.Multiple attempts were made to request additional information.Based on the information provided to date, no conclusion can be made as to the degree to which the device, may be causing or contributing the patient¿s reported symptoms.The instructions-for-use supplied with the device lists infection and seroma as possible complications.In regards to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." note, as a specific date was not provided, the date of implant is reported as a best estimate (b)(6) 2020).Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
As reported, the patient was implanted with a bd/davol phasix mesh in (b)(6) 2020.It is alleged that the patient had a jackson-pratt (jp) drain for 10 months and has been sick since the implant of the mesh.The drain was removed and a seroma was identified.It is also alleged that there was a hole in the abdomen with drainage and necrotic tissue was found, and surgery was delayed due to covid-19.The mesh was later explanted and the patient has a 7 inch scar.As reported, the patient has issues with the phasix hernia mesh (infection and necrosis) and also that the mesh did not disintegrate, causing the patient to get sick.

• Brand Name: PHASIX MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10606647
• Report Number: 1213643-2020-08919
• Device Sequence Number: 2445625
• Product Code: OOD
• UDI-Device Identifier: 00801741077685
• UDI-Public: (01)00801741077685
• Combination Product (Y/N): N
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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: 12/28/2020
• Device Catalogue Number: 1190300
• Device Lot Number: HUCY0698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention