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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); Insufficient Information (3190)
Patient Problem Injury (2348)
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 bard/davol mesh ¿ composix (device #1) and the bard/davol xenmatrix (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 composix on (b)(6) 2004 and two xenmatrix on (b)(6) 2012. As reported, the patient is making a claim for an adverse patient outcome against all devices. Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device. It is also alleged 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 Key10642259
MDR Text Key210213387
Report Number1213643-2020-09046
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 consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2020
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: 10/07/2020 Patient Sequence Number: 1
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