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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX MESH E/X SURGICAL MESH Back to Search Results
Catalog Number 0123680
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Hernia (2240); Disability (2371)
Event Date 03/27/2012
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, recurrence, adhesions, inflammation and subsequent surgical intervention. The instructions-for-use supplied with the device lists 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 composix mesh e/x (device #1). An additional emdr was submitted to represent the bard flat mesh (device #2). Should additional information be provided, a supplemental emdr will be submitted. Not returned.

 
Event Description

Attorney alleges that, on or about (b)(6) 2011, the patient underwent repair of a lower midline hernia and was implanted with composix ex mesh. On or about (b)(6) 2012, the patient underwent revision of the composix e/x and a non-bard/davol mesh was implanted. On or about (b)(6) 2012, the patient underwent revision of the composix e/x and non bard/davol mesh and then was implanted with 6 x 6 in. Marlex mesh (bard flat mesh). On or about (b)(6) 2014, the patient underwent removal of composix e/x, bard marlex mesh (bard flat mesh) and non bard/davol mesh. It is alleged that the patient experienced and/or continues to experience severe and chronic pain, inflammation, eventration of the mesh, pelvic mass, necrosis, scarring, adhesions to small intestine and bowel, and surgery to remove the meshes. 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 NameCOMPOSIX MESH E/X
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 Key11381205
MDR Text Key233754180
Report Number1213643-2021-01313
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK002684
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 Date08/28/2012
Device Catalogue Number0123680
Device LOT NumberHURG1016
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 Manufactured08/29/2007
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: 02/25/2021 Patient Sequence Number: 1
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