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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); Detachment of Device or Device Component (2907); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Inflammation (1932); Disability (2371)
Event Date 04/15/2015
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, adhesions, inflammation and subsequent surgical intervention. The instructions-for-use supplied with the device lists adhesions, inflammation as possible complications. A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification. Should additional information be provided, a supplemental emdr will be submitted. Not returned.

 
Event Description

Attorney alleges that on or about (b)(6) 2012, the patient underwent surgery for the repair of an umbilical hernia. A non-bard/davol product was implanted to repair the hernia. It is alleged on (b)(6) 2013, the patient underwent revision surgery and a bard/davol composix kugel mesh was implanted to repair a hernia. It is alleged on or about (b)(6) 2015, the patient underwent further revision surgery and removal of the meshes. It is alleged that the patient has suffered and will continue to suffer severe and chronic pain, inflammation, adhesions, mesh detachment, and surgery to remove the meshes. Attorney alleges general allegations for "past, present, and future damages, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by the patient. " attorney also alleges 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 Key11379854
MDR Text Key233697477
Report Number1213643-2021-01307
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
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 Date06/28/2016
Device Catalogue Number0010205
Device LOT NumberHUVF0085
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 Manufactured06/27/2011
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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