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

Catalog Number	1200015
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Seroma (2069)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided and review of the medical records, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the patients postoperative seroma formation and subsequent infection.Seroma formation is a known inherent risk of surgery including hernia repair, abdominoplasty and liposuction all of which were performed on the patient on (b)(6) 2017.Based on medical record review the cause for the postoperative seroma formation and subsequent infection is unknown.No conclusion can be made.A lot number was not provided, without a lot number a review of the manufacturing records is not possible.Seroma formation is identified in the instructions-for-use as a possible complication.Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The following is based on medical records: (b)(6) 2017 - the patient was diagnosed with a unilateral inguinal hernia, umbilical hernia, lipodystrophy and underwent repair of multiple abdominal hernias, abdominoplasty and liposuction.During this procedure the patient was implanted with a bard/davol phasix st mesh.On (b)(6) 2017 - the patient had follow up office visit with complaints of right groin pain.On (b)(6) 2017, (b)(6) 2017 - the patient underwent an ultrasound guided, left anterior abdominal wall subcutaneous seroma aspiration procedure.On (b)(6) 2017 - the patient was diagnosed with an infection and inflammatory reaction due to the mesh (phasix st) implant and underwent an ultrasound guided, left anterior abdominal wall subcutaneous seroma aspiration procedure.On (b)(6) 2017 - the patient underwent an abdominal wall exploration with removal of the bard/davol phasix st mesh with a post operative surgical drain placed.The following was reported by the contact: the patient currently works out regularly; however, is having difficulty with abdominal exercising and strengthening and has been experiencing a lot of swelling and soreness in the area of her ventral hernia repair.The patient has consulted with a couple different surgeons who stated they cannot help her.

• 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: 8709643
• Report Number: 1213643-2019-05180
• Device Sequence Number: 2090900
• Product Code: OWT
• UDI-Device Identifier: 00801741095290
• UDI-Public: (01)00801741095290
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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 Catalogue Number: 1200015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/18/2019
• 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
• Patient Age: 55 YR
• Patient Weight: 65