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

Catalog Number	1161015
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/16/2018
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 graft may have caused or contributed to the patient's reported staph infection.As reported approximately six years post implant the patient was diagnosed with a staph (b)(6) infection, which can typically be acquired during hospital stays / visits.Additionally, medical implants are not frequently the cause of these types of recurrent infections but rather a vantage point that the bacteria use.Infection is listed in the adverse reaction section of the instructions-for-use as a possible complication.Should additional information be obtained, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
It was reported that on (b)(6) 2011 the patient was implanted with a bard xenmatrix graft.The graft was place in a clean procedure.As reported approximately six years later the patient developed a (b)(6) infection, which has recurred three times.On (b)(6) 2018 a revision procedure was performed with excision of the fascia, scar tissue and explant of potential bio mesh remnant (xenmatrix graft).The contact reports the culture came back positive for staff infection.

• 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: 8041118
• Report Number: 1213643-2018-03867
• Device Sequence Number: 13778593
• Product Code: FTM
• UDI-Device Identifier: 00801741031380
• UDI-Public: (01)00801741031380
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K081272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2018

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: 1161015
• Device Lot Number: HUVCBL30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/06/2018
• 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: 79 YR