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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. KUGEL PATCH SURGICAL MESH Back to Search Results
Catalog Number 0010101
Device Problems Defective Device (2588); Folded (2630); Material Deformation (2976)
Patient Problems Unspecified Infection (1930); Pain (1994); Sepsis (2067)
Event Date 05/23/2005
Event Type  Injury  
Manufacturer Narrative
The medical records indicate the patient experienced a "recurrent ventral incisional hernia. " recurrence is listed as a possible adverse reaction in the instructions-for-use. While the medical records indicate the patient experienced infection/sepsis, it appears based on the information provided that the infection was related to the composix kugel mesh and not to the kugel patch. With the current information available at this time, no definitive conclusion can be made as to the extent that the kugel mesh may have caused or contributed to the patient's symptoms experienced after implant. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. This file represents the kugel mesh implanted in 2004, a second file had already been opened to address the composix kugel mesh implanted in 2005. 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 to manufacturer.
 
Event Description
The following is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 2004 - the patient underwent repair of a ventral incisional hernia with implant of a kugel mesh. No operative details were provided for this procedure. On (b)(6) 2005 - the patient underwent repair of a recurrent ventral incisional hernia with implant of a composix kugel hernia mesh. No operative details were provided for this procedure. On (b)(6) 2012 - the patient was diagnosed with abdominal pain, sepsis and lymphadenopathy. The patient underwent an exploratory laparotomy, small bowel resection, lysis of adhesions and partial removal of an infected composix kugel mesh and explant of the bard kugel patch. The operative details indicated "on ct scan, there was a fluid collection deep to the mesh and the mesh was incised and purulent drainage was immediately found. " in addition the operative details note that when encountering the mesh "this was a composix type mesh with an underlying prolene layer and then a gore layer deep to that. On one side of the mesh it had become separated from the abdominal wall and was actually extending down into the abdomen cavity and on the prolene side of the mesh, small bowel had become adherent to this and erosion and a fistula had formed. " per notes all of the "gore" material was removed and most of the prolene mesh was removed as well. Based on a legal affidavit signed by the physician on (b)(6) 2015, "the patient's mesh was folded over and small bowel was adherent to mesh. Impossible to tell from this whether mesh was prolene. Defective with certainty. Fistula was due to contact of small bowel to unprotected prolene mesh. ".
 
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Brand NameKUGEL PATCH
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 Key6390876
MDR Text Key69489041
Report Number1213643-2017-00168
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963141
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 11/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2009
Device Catalogue Number0010101
Device Lot Number43BOD216
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
Date Device Manufactured02/15/2004
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: 03/09/2017 Patient Sequence Number: 1
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