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

Catalog Number	1201520
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be made.Based on the information provided we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as reported.Bard/davol products are provided to the customer in a sterile state.At this time the patient is recovering at home, with no additional reported complications.Infection and seroma are known inherent risks of any surgical procedure and are identified in the adverse reactions section of the instructions-for-use as possible complications.A manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification should additional information be provided, a supplemental emdr will be submitted.Remains implanted.
Event or Problem Description
It was reported that in (b)(6) 2019 the patient was implanted with a bard/davol phasix st mesh during an abdominal wall repair procedure.Postoperatively the patient was treated with antibiotics for a possible infection.The surgeon requested a surgeon to surgeon consult regarding the patient's treatment.The surgeon reports that she was satisfied with the treatment plan that was discussed during the consult.As reported the surgeon will continue to treat the patient with antibiotics throughout this time.Currently the wound is closed and the patient is recovering from the surgery in her home.Also reported was fluid build up, it is unclear if this is a seroma, or extra fluid from the resorption of the st barrier, which is not uncommon in the postoperative time period.

• Brand Name: PHASIX ST 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: 8587927
• Report Number: 1213643-2019-03658
• Device Sequence Number: 13869740
• Product Code: OWT
• UDI-Device Identifier: 00801741095368
• UDI-Public: (01)00801741095368
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

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: 10/28/2020
• Device Catalogue Number: 1201520
• Device Lot Number: HUCX1935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/07/2019
• 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