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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 XENMATRIX PORCINE SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 XENMATRIX PORCINE SURGICAL MESH Back to Search Results
Catalog Number 1161935
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abscess (1690); Bacterial Infection (1735)
Event Date 12/14/2015
Event Type  Injury  
Manufacturer Narrative
As reported, post implant of the xenmatrix graft and bowel resection procedure, the patient was diagnosed with a surgical site infection and abscess. The clinician has assessed the patient¿s postoperative course of surgical site infection and abscess as possibly related to the study device and possibly related to the procedure. However, based on the information provided, no conclusion can be made. Review of manufacturing records confirms product was manufactured to specification. To date, this is the only reported complaint for this manufacturing lot of 16 units released for distribution in (b)(6) 2015. Infection is an known inherent risk of surgery and is listed as a possible complications in the instructions-for-use (ifu) supplied with the device. In regards to infection, the warnings section of the ifu states, "if an infection develops, it should be treated aggressively. ".
 
Event Description
Alleged per clinical trial dvl-he-020: on (b)(6) 2015, the subject patient underwent first time recurrent midline incisional open hernia repair procedure, during which a xenmatrix surgical graft was trimmed and placed in underlay fashion intra-peritoneally, fixated using maxon sutures with interrupted stitch technique. The fascia closure was achieved using vicryl sutures with interrupted stitch technique and full skin closure was achieved using sutures. The patient was discharged on (b)(6) 2015. Concomitant procedure includes lysis of adhesion(s) and bowel resection. On (b)(6) 2015, the subject patient was diagnosed with surgical site infection and abscess. The patient underwent drainage culture test, resulted in positive for methicillin-resistant staphylococcus aureus. The patient was hospitalized and underwent drain insertion using interventional radiology, and treated with oral antibiotics. The patient was discharged to home on (b)(6) 2015 and the ae was resolved on (b)(6) 2016. On (b)(6) 2016, the subject patient was diagnosed with surgical site infection and abscess. The patient underwent drainage culture test, which resulted in no identification of pathogens. The patient was hospitalized on 09-feb-2016 and underwent drain insertion using interventional radiology, and treated with oral antibiotics. The patient was discharged to home on (b)(6) 2016 and the ae was resolved on (b)(6) 2016. The ae is clinically assessed to be of mild severity, possibly related to the study device and possibly related to the procedure and recovered/resolved. The reported adverse meets the definition of an sae (serious adverse event) and does not meet uade (unlisted adverse device event).
 
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Brand NameXENMATRIX
Type of DevicePORCINE SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
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
8005566756
MDR Report Key15294391
MDR Text Key298602923
Report Number1213643-2022-00594
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00801741031441
UDI-Public(01)00801741031441
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,Study,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/28/2017
Device Catalogue Number1161935
Device Lot NumberHUZG0240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/25/2022 Patient Sequence Number: 1
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