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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 UNKAA081
Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient. The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. This emdr represents the bard/davol xenmatrix (device #2). Additional emdrs were submitted to represent the two bard/davol ventralex (device #1 and device #3). Should additional information be provided, a supplemental emdr will be submitted. Not returned.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol ventralex hernia patch and xenmatrix on (b)(6) 2010 and/or (b)(6) 2012 and/or (b)(6) 2020. As reported, the patient is making a claim for an adverse patient outcome against all the devices. It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device. Attorney alleges that the patient experienced emotional distress and the device was defective.
 
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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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key12860115
MDR Text Key281135468
Report Number1213643-2021-08839
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140501
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA081
Was Device Available for Evaluation? No
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/23/2021 Patient Sequence Number: 1
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