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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX SURGICAL MESH Back to Search Results
Catalog Number 1161015
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Hernia (2240); Injury (2348); Disability (2371)
Event Date 03/11/2016
Event Type  Injury  
Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any the bard xenmatrix biologic (device #2) may have caused or contributed to the events as alleged by the patient¿s attorney. The information provided alleges that the patient would need a third surgery "because the initial repair and the second emergency surgery failed" however the patient's attorney did not allege a specific device failure and medical records are not available at this time. No lot number has been provided; therefore a review of the manufacturing records is not possible at this time. Based on the limited information provided at this time, no conclusions can be made. Should additional information be provided a supplemental emdr will be submitted. This emdr represents the bard bard xenmatrix biologic (device #2) implanted on (b)(6) 2015. An additional emdr was submitted to represent the ventralex (device #1) implanted on (b)(6) 2015. 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. Not returned.
 
Event Description
The following was alleged by the patient's attorney: on (b)(6) 2015: the patient underwent surgery for an umbilical hernia repair, in which a bard/davol ventralex hernia patch (device #1) was utilized. On (b)(6) 2015: the patient was feeling ill and dehydrated and he was taken to the emergency room where it was concluded that the patient's symptoms were related to the hernia repair. It is alleged, the surgeon performed an emergency revision surgery to repair the hernia mesh, applying a bard/davol xenmatrix biologic implant mesh (device #2), over the existing ventralex hernia mesh patch. As reported, the patient remained hospitalized for five days after this procedure and over the next two months, the patient continued to experience ill effects and drainage from his wound. As reported, a few months later, it was determined that the patient would need a third surgery, because the initial repair and the second emergency surgery failed. On (b)(6) 2016: "a different hernia mesh" was utilized as the patients continued medical problems and subsequent hospitalizations were the result of the defective ventralex hernia patch mesh. As alleged, the patient has suffered injuries and damages and has suffered serous and permanently injuries to his body, including physical pain, and permanently bodily impairment.
 
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Brand NameXENMATRIX
Type of DeviceSURGICAL 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
francesca santamaria
100 crossings blvd.
warwick, RI 02886
4018258538
MDR Report Key7244637
MDR Text Key99129370
Report Number1213643-2018-00202
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 consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2016
Device Catalogue Number1161015
Device Lot NumberHUYH0166
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2018
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: 02/06/2018 Patient Sequence Number: 1
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