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

Catalog Number	1200011
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided this is a patient with a complex medical / surgical history.At this time, no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the patient outcome.However, based on the event as reported it is likely that the patient's pre-existing conditions complicated her postoperative course.No lot number has been provided; therefore no dhr review and related manufacturing process reviews could be performed.Extrusion is a known inherent risk of hernia repair surgery, and is listed in the instructions-for-use as a possible complication.Should additional information be provided, a supplemental emdr will be submitted.Remains implant.
Event or Problem Description
The following was reported to davol: on (b)(6) 2019 the patient, who has a complex surgical history which includes a colon resection and colostomy, underwent reversal of the colostomy.At this time the surgeon placed a phasix st mesh to aid in closure of the abdomen.As reported, the patients surgical wound has not fully healed since the procedure and the patient continues to have dressing changes and treatment provided by the wound clinic.Also reported, the surgeon has advised the patient that she is not a candidate to undergo additional surgical intervention to remove the mesh as the surgeon stated "there is nothing left to work with." as reported, the patient has had multiple abdominal surgeries and as stated, she "died on the table" during one of her previous procedures.As reported, there are pieces of the mesh protruding from the open area of the wound.

• Brand Name: PHASIX ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9179615
• Report Number: 1213643-2019-09864
• Device Sequence Number: 11405158
• Product Code: OWT
• UDI-Device Identifier: 00801741095283
• UDI-Public: (01)00801741095283
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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: 1200011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/11/2019
• 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