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

Catalog Number	1161928
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Impaired Healing (2378)
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 xenmatrix grafts may have caused or contributed to the events as alleged.The contact provided limited information.Infection is a known inherent risk of surgery and is listed in the adverse reaction section of the instructions-for-use as a possible complication.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in june, 2011.A manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification.Infection is a known inherent risk of surgery and is listed in the adverse reaction section of the instructions-for-use as a possible complication.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in april, 2011.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 file represents device #1, an additional emdr was submitted to represent device #2.
Event or Problem Description
It was reported that on (b)(6) 2011 the patient underwent repair of an abdominal hernia and was implanted with two xenmatrix grafts (devices #1 and #2), and a non bard/davol biologic graft (device #3).The contact reports the hernia repair wound never fully healed, and in 2014 the patient developed an infection in the area of the hernia repair.As reported the patient's doctor has advised him the mesh will need to be removed.

• Brand Name: XENMATRIX
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7980491
• Report Number: 1213643-2018-03608
• Device Sequence Number: 11201487
• Product Code: FTM
• UDI-Device Identifier: 00801741031434
• UDI-Public: (01)00801741031434
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2018

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: 03/28/2013
• Device Catalogue Number: 1161928
• Device Lot Number: HUVCBL25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/18/2018
• 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: 59 YR