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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 0010202
Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Hernia (2240); Disability (2371)
Event Date 01/17/2006
Event Type  Injury  
Manufacturer Narrative

No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, adhesions, inflammation, chronic pain, mesh detachment and surgical intervention due to the hernia mesh device. The instructions-for-use supplied with the device lists hernia recurrence, adhesions, and inflammation as possible complications. A review of the manufacturing records was performed and found that the lot was manufactured to specification. This emdr represents the bard/davol mesh - composix kugel (device #1). An additional emdr was submitted to represent the bard/davol mesh - composix kugel (device #2). Should additional information be provided, a supplemental emdr will be submitted. Not returned.

 
Event Description

Attorney alleges that on (b)(6) 2005, the patient had a large oval bard/davol composix kugel mesh implanted to repair a hernia defect. It is alleged that on or about (b)(6) 2006, the patient underwent surgery to revise the initial kugel mesh and a second bard/davol composix kugel mesh, medium was implanted to repair a recurrent hernia defect. On or about (b)(6) 2008, the patient underwent removal surgery of the kugel meshes and a non-bard/davol product was implanted during this procedure. Attorney alleges that the patient underwent additional revision surgery on (b)(6) 2008 and removal surgeries of one of the mesh products on (b)(6) 2008, (b)(6) 2009 and (b)(6) 20012. Attorney alleges that the patient has suffered and will continue to suffer severe and chronic physical pain, mental anguish, multiple surgeries to remove mesh, scarring, dense adhesions, adhesions to small bowel, mobile or detached mesh, abdominal wall reconstruction, inflammation, and recurrence. Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient. " it is also alleged that the device was defective.

 
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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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key11377573
MDR Text Key233532226
Report Number1213643-2021-01210
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 02/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/28/2010
Device Catalogue Number0010202
Device LOT Number43CPD327
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/03/2005
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: 02/25/2021 Patient Sequence Number: 1
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