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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 Bacterial Infection (1735); Hernia (2240)
Event Date 08/18/2015
Event Type  Injury  
Manufacturer Narrative
As reported, post implant of the xenmatrix graft, the patient was diagnosed with a hernia recurrence, and subsequent infection. Patient underwent additional surgery for removal of the graft. The clinician has assessed the patient¿s postoperative course as being 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 (b)(4) units released for distribution in may 2014. Hernia recurrence and infection are known inherent risks of the surgery and are included as possible complications in the adverse reactions section of the instructions-for-use (ifu), supplied with the device. Regarding infection, the warnings section of the ifu states, " if an infection develops, it should be treated aggressively. ¿ not returned - mesh explanted.
 
Event Description
Per clinical trial dvl-he-020: on (b)(6) 2015, the patient underwent primary open hernia repair procedure for ventral hernia in llq location during which a xenmatrix surgical graft was trimmed and placed in underlay fashion in the intra-peritoneal region using sutures. Full skin closure was achieved using sutures with figure-8 technique. Concomitant procedure includes debridement of abdominal wall nonhealing wound. The patient was discharged on (b)(6) 2015. As reported, during a physical examination on (b)(6) 2015 the patient was diagnosed with ventral hernia recurrence in llq location. As reported on (b)(6) 2015, the patient was diagnosed with surgical site infection (ssi) and the culture test for the tissue was positive for staphylococcus aureus and treated with oral antibiotics/antimicrobials and resolved on (b)(6) 2016. It was reported that on (b)(6) 2016, the patient underwent reoperation to repair hernia recurrence and the graft was removed completely. Full skin closure was achieved using vicryl interrupted stitch. The patient was discharged on (b)(6) 2016. The ae (hernia recurrence and surgical site infection (ssi)) is clinically assessed to be moderate in severity, possibly related to the study device and possibly related to the index procedure and recovered/resolved. The reported ae (hernia recurrence) does meet the definition of serious (sae) and ae (surgical site infection (ssi)) does not meet the definition of serious (sae).
 
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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 Key15257799
MDR Text Key298208826
Report Number1213643-2022-00587
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 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2016
Device Catalogue Number1161935
Device Lot NumberHUYD1102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2014
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: 08/19/2022 Patient Sequence Number: 1
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