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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); Material Deformation (2976); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Hernia (2240); Disability (2371)
Event Date 04/06/2011
Event Type  Injury  
Manufacturer Narrative

No conclusions can be made. The patient's attorney alleges adverse patient outcomes associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, adhesions and surgical intervention. The instructions-for-use supplied with the device lists adhesions and hernia recurrence as possible complications. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be provided, a supplemental emdr will be submitted.

 
Event Description

Attorney alleges that on or about (b)(6) 2008, the patient underwent surgery for repair of an incisional hernia. A composix kugel patch was implanted to repair the hernia defect. It is alleged that on or about (b)(6) 2011, the patient underwent additional surgery to repair a massive ventral hernia during this procedure the composix kugel patch was found to be bunched up and it was found that the patient's small intestine had become imbedded to the undersurface of the mesh. The composix kugel patch was partially dissected and a non-bard davol mesh was implanted to repair the defect. It is alleged that the patient was injured severely and permanently. The patient suffered pain, disability, hospitalizations and additional surgeries. It is also alleged that the patient has suffered and will continue to suffer physical pain, chronic pain, mental anguish, psychological stress, depression, has undergone and will likely require medical treatments and other forms of care. 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 Key10686770
MDR Text Key211725687
Report Number1213643-2020-09467
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCA
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 10/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2012
Device Catalogue Number0010202
Device LOT NumberHURD2717
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/16/2007
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: 10/15/2020 Patient Sequence Number: 1
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