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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 Problem Hernia (2240)
Event Date 03/28/2016
Event Type  Injury  
Event Description
Alleged per clinical study dvl-he-020: on (b)(6) 2014, the subject patient underwent multiple recurrent ventral midline open hernia repair procedure, during which a xenmatrix surgical graft was trimmed and placed in inlay fashion on the intra-peritoneal region using a suture (maxon). Fascia was completely closed with vicryl suture in interrupted stitch technique and full closure was achieved with sutures. The patient was discharged on (b)(6) 2014. Concomitant procedure includes lysis of adhesion(s) and prior mesh removal. As reported, during a physical examination on (b)(6) 2016, the patient was diagnosed with ventral midline hernia recurrence and confirmed through ct scan on (b)(6) 2016. On (b)(6) 2016, patient underwent a hernia repair procedure during which the device was partially explanted. Fascia was completely closed with vicryl suture in interrupted stitch technique and full closure was achieved. The patient was discharged on (b)(6) 2016. The ae is clinically assessed to be of moderate severity, definitely related to the study device, not related to the procedure and recovered/resolved. The reported adverse event meets the definition of an sae (serious adverse event) and does not meet the uade (unanticipated adverse device effect).
 
Manufacturer Narrative
As reported, post implant of the xenmatrix graft , the patient with a history of recurrence hernia, was diagnosed with a recurrent hernia and underwent partial explant. The clinician has assessed the patient¿s postoperative course as definitely related to the study device and not related to the procedure. However, based on the information provided, no conclusion can be made. Hernia recurrence is a known inherent risk of surgery and is listed as a possible complication in the instructions-for-use supplied with the device. Review of manufacturing records confirms product was manufactured to specification. To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in august 2014.
 
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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 Key15257808
MDR Text Key298205044
Report Number1213643-2022-00586
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 08/04/2022
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 Date07/28/2016
Device Catalogue Number1161935
Device Lot NumberHUYG1507
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 Manufactured08/15/2014
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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