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

Catalog Number	1203035
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930)
Date of Event	01/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be made.Based on the information provided it is unknown to what extent, it any, the bard devices may have caused or contributed the patient's postoperative condition.At this time, the surgeon reports that she does not know what is causing the infection.To date this is the only reported complaint for this production lot of 45 units released for distribution in may, 2018.A manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification.Should additional information be obtained, a supplemental emdr will be submitted.This emdr represents the bard phasix st (device #1), an additional emdr was submitted to represent the bard soft mesh (device #2).Note: remains implanted.
Event or Problem Description
The following was reported.On (b)(6) 2018 - the patient underwent the "repair of 6 various ventral hernias ranging from incision at the midline to lateral on both left and right side.Surgeon dissected individual layers of abdominal wall, including transversus abdominal release in order to close all defects.The patients posterior rectus sheath was extremely weak and continued to tear as defects were closed under very little tension.Decision was made to use bard phasix st (device #1) intra-abdominally to protect the viscera and provide structure for posterior rectus sheath to remodel.Additionally, the surgeon felt as though she wanted to add another layer of permanent mesh, bard soft mesh (device #2) was used in the retro rectus space to ensure that the hernias would not return.All layers of the abdominal wall were closed and drains were placed." "after repairing the hernias, placing the mesh and closing the abdomen, the surgeon continued to perform a panniculectomy." the panniculectomy contributed to case being almost 6 hours long.On (b)(6) 2019 - the patient was admitted due to postoperative intra-abdominal abscess and infection and is currently undergoing antibiotic therapy.The surgeon reports that she does not know what is causing the infection, but she will treat the patient with 6 weeks to 6 months of aggressive antibiotics before attempting a reoperation as the patient is too compromised undergo additional surgery at this time.

• 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: 8286304
• Report Number: 1213643-2019-00518
• Device Sequence Number: 13494748
• Product Code: OWT
• UDI-Device Identifier: 00801741095382
• UDI-Public: (01)00801741095382
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

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: 04/28/2020
• Device Catalogue Number: 1203035
• Device Lot Number: HUCP2387
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2019
• Initial Report FDA Received Date: 01/29/2019
• 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: 63 YR
• Patient Weight: 127