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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX PORCINE SURGICAL MESH Back to Search Results
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.
 
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Brand NameXENMATRIX
Type of DevicePORCINE 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 Key7515729
MDR Text Key108304363
Report Number1213643-2018-01501
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081272
Number of Events Reported1
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 Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/28/2015
Device Catalogue Number1162025
Device Lot NumberHUXA0435
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 Received04/27/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2013
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
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