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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 Problem Insufficient Information (3190)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Respiratory Distress (2045)
Event Date 04/07/2017
Event Type  Injury  
Manufacturer Narrative
A definitive conclusion for the patient's condition cannot be made at this time. There are many factors that may have contributed to the patient¿s condition, including the patient¿s history of bladder cancer with radiation and chemotherapy treatment, the placement of the graft around the ileal conduit (which is made out of tissue from the intestine and risks the presence of bacteria), and the fascia not being able to close over the graft. A lot number was not provided therefore a review of the manufacturing records is not possible. The instructions for use provided with the device states, "if an infection develops, it should be treated aggressively. " "when unable to close skin over the xenmatrix surgical graft, ensure that the implant remains moist. Avoid drying of the implant through ¿continued suction device¿ as this may negatively impact the performance of the implant" "place device in maximum possible contact with healthy, well vascularized tissue to promote cell ingrowth and tissue remodeling" the adverse reactions section lists infection and hematoma as potential complications. Should additional information be provided, a supplemental mdr will be submitted. 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. Device not returned.
 
Event Description
The following was reported to davol: (b)(6) 2017 - the patient was implanted with a bard xenmatrix graft for the treatment of a parastomal ventral hernia. The patient has a history of bladder cancer and the graft was placed as an underlay with a keyhole around the ileal conduit. As reported the fascia was unable to be closed over the graft. (b)(6) 2017 - eight days postoperatively, the patient developed a postoperative infection which included fluid drainage and an increased white blood cell count. The patient's surgical wound was cultured and was positive with growth of the bacteria, staph aureus, and a postoperative hematoma was noted superior to the graft. The patient was prescribed iv antibiotics and placed on a ventilator as the patient experienced acute respiratory distress due to the infection. (b)(6) 2017 - the patient was taken to the or to have an additional surgical procedure performed which included an abdominal wound washout and removal of the superficial layer of the xenmatrix graft. The patient had an abdominal wound drain placed and remains in the hospital. Per the surgical resident, the patient's white blood cell count has improved since; however, the patient remains on a ventilator. The physician reports that the exact source of the infection is unknown as the patient has a history of bladder cancer with chemotherapy and radiation treatments.
 
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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 berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6530512
MDR Text Key73960595
Report Number1213643-2017-00276
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2017
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: 04/28/2017 Patient Sequence Number: 1
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