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

Catalog Number 1161015

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 10/16/2018

Event Type  Injury  

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 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
• Type of Device: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 8041118
• MDR Text Key: 126217665
• Report Number: 1213643-2018-03867
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00801741031380
• UDI-Public: (01)00801741031380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2013
• Device Catalogue Number: 1161015
• Device Lot Number: HUVCBL30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR