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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX KUGEL SURGICAL MESH Back to Search Results
Catalog Number 0010208
Device Problems Break (1069); Defective Device (2588); Folded (2630)
Patient Problems Erosion (1750); Unspecified Infection (1930); Bowel Perforation (2668)
Event Date 11/12/2015
Event Type  Injury  
Manufacturer Narrative
The medical records indicate the patient was treated for adhesions and infection. Adhesions is listed as a known adverse reaction in the instructions-for-use. In regards to infection, the warning section of the instructions-for-use states ¿if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ a manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event. While it was reported that the mesh ring broke, the mesh was not returned for evaluation therefore a cause for the ring break could not be determined at this time. Based on the information provided no definitive conclusion can be made as to whether the composix kugel mesh may have caused or contributed to the events experienced due to the patient's multiple abdominal surgical procedures performed. If additional event and/or evaluation information is obtained, a follow up 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 to manufacturer.
 
Event Description
The following is based on a review of medical records provided to davol by the patient's attorney: in (b)(6) 2005 - the patient underwent exploratory laparotomy with partial gastrectomy to repair perforated ulcer. On (b)(6) 2005 - patient underwent a repair procedure of a dehisced abdominal wound incision. On (b)(6) 2007 - patient was diagnosed with incisional hernias and underwent repair with implant of a bard/davol composix kugel hernia patch using a bard davol salute fasteners. On (b)(6) 2015 - patient had an md office exam with complaints of abdominal pain a nauseated feeling for the course of a month as well as anorexia with uninintentional weight loss. A ct performed found an abscess with or without fistula in the area of the old mesh. On (b)(6) 2015 - patient was diagnosed with an infected abdominal mesh and underwent explantation of the composix kugel mesh, a small bowel resection and repair of ventral incisional hernia with a non bard davol biologic mesh. The operative details indicated the composix kugel mesh was "fairly well incorporated; however, in the left upper quadrant, the mesh was folded and had eroded into the small bowel. It was densely adherent and while dissecting the mesh, there was noted to be an area that appeared to be within the lumen of the small bowel. The mesh had somewhat folded on itself, and the ring of the mesh was broken in that spot. There were two areas of small bowel that had been adherent to each other and eroded by the mesh. " on (b)(6) 2015 - patient had a postoperative follow up visit indicating the patient was doing well and had her jp drains. On (b)(6) 2015 - patient¿s skin noted during an office exam to have some dehiscence, however, her fascia was intact and noted to be granulating well.
 
Manufacturer Narrative
Addendum to the initial report. This supplemental is being sent to show an update to the outcomes attributed to adv ev section. With the current information, no conclusion can be made. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. Not returned to manufacturer.
 
Event Description
The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 2005 - the patient underwent exploratory laparotomy with partial gastrectomy to repair perforated ulcer. On (b)(6) 2005 - patient underwent a repair procedure of a dehisced abdominal wound incision. On (b)(6) 2007 - patient was diagnosed with incisional hernias and underwent repair with implant of a bard/davol composix kugel hernia patch using a bard davol salute fasteners. On (b)(6) 2015 - patient had an md office exam with complaints of abdominal pain a nauseated feeling for the course of a month as well as anorexia with unintentional weight loss. A ct performed found an abscess with or without fistula in the area of the old mesh. On (b)(6) 2015 - patient was diagnosed with an infected abdominal mesh and underwent explantation of the composix kugel mesh, a small bowel resection and repair of ventral incisional hernia with a non bard davol biologic mesh. The operative details indicated the composix kugel mesh was "fairly well incorporated; however, in the left upper quadrant, the mesh was folded and had eroded into the small bowel. It was densely adherent and while dissecting the mesh, there was noted to be an area that appeared to be within the lumen of the small bowel. The mesh had somewhat folded on itself, and the ring of the mesh was broken in that spot. There were two areas of small bowel that had been adherent to each other and eroded by the mesh. " on (b)(6) 2015 - patient had a postoperative follow up visit indicating the patient was doing well and had her jp drains. On (b)(6) 2015 - patient's skin noted during an office exam to have some dehiscence, however, her fascia was intact and noted to be granulating well.
 
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Brand NameCOMPOSIX KUGEL
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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key5785329
MDR Text Key49279064
Report Number1213643-2016-00314
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061314
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 06/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2012
Device Catalogue Number0010208
Device Lot NumberHURB4470
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received07/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2007
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: 07/12/2016 Patient Sequence Number: 1
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