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

Catalog Number 1162025

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

At this time the cause of the patient's postoperative complications cannot be determined. The physician reports that he does not believe the patient's symptoms to be related to the xenmatrix graft and is considering other causes as he continues to assess the patient's condition. Based on the information provided to date no conclusion can be made. Should additional information be obtained, a supplemental emdr will be submitted. Note: the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Remains implanted.

Event Description

The physician (not implanting physician) reported that a patient who had been implanted with a davol xenmatrix graft on (b)(6) 2013 came to his office requesting that the hernia graft be removed. When initially placed the graft which had been sized from 20x25 to a 16x20 prior to implant was placed into the retro rectus tissue plain in an open procedure. As reported 6 to 12 months post implant the patient's symptoms (red skin / reaction) began. The physician reports that he reviewed her ct images and the mesh was fully incorporated and there appeared to be no fluid collection. The physician reports that he is uncomfortable with surgically trying to remove the mesh because he is not confident the mesh is the root cause of her symptoms and because he believes the graft would be fully incorporated into her tissue and has likely been fully resorbed. He said that he does not believe the patient's symptoms are related to the graft. The physician reports that he believes it may be erythema ab igne or some sort of ¿immune, vasculitis or endocrine problem¿. He is also considering referring her to a dermatologist or rheumatologist.

• 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: 7515729
• MDR Text Key: 108304363
• Report Number: 1213643-2018-01501
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00801741031465
• UDI-Public: (01)00801741031465
• 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

• Type of Report: Initial
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/28/2015
• Device Catalogue Number: 1162025
• Device Lot Number: HUXA0435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/15/2018 Patient Sequence Number: 1