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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. MESH - COMPOSIX KUGEL SURGICAL MESH Back to Search Results
Catalog Number 0010205
Device Problems Defective Device (2588); Folded (2630)
Patient Problems Adhesion(s) (1695); Obstruction/Occlusion (2422)
Event Date 07/11/2015
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event. While medical records were provided they were limited to an implant tracking log and explant operative report only. As stated in the medical records this is a patient with a history significant for "multiple abd surgeries. " no medical records were provided between the time of implant of the composix kugel mesh and explant of the device, therefore it is unclear if the reported "multiple abd surgeries" may have contributed to the report of significant adhesions. Based on a review of medical records, the patient experienced obstruction and adhesions. Adhesions are listed as a known possible adverse reaction in the instructions-for-use. A manufacturing review was performed and found no anomalies during the manufacturing process. With the current information available no definitive conclusion can be made at this time. 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. 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) 2007 - the patient underwent repair of a ventral hernia with use of a bard composix kugel hernia patch. No operative details were provided for this procedure. On (b)(6) 2015 - the patient was diagnosed with a small bowel obstruction and underwent partial explant of the composix kugel mesh, a small bowel resection and adhesiolysis. Per the operative details the mesh was removed "given the fact the mesh portion that was exposed to the peritoneal cavity. " operative findings further indicated the prior composix kugel mesh was folded over with small bowel adherent to the mesh part causing obstruction. Adhesions were significant.
 
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Brand NameMESH - COMPOSIX 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 Key6389245
MDR Text Key69437414
Report Number1213643-2017-00162
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial
Report Date 03/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2011
Device Catalogue Number0010205
Device Lot Number43FQD194
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 Received02/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2006
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: 03/08/2017 Patient Sequence Number: 1
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