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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX E/X SURGICAL MESH Back to Search Results
Catalog Number UNKAA015
Device Problem Defective Device
Event Date 05/19/2015
Event Type  Injury  
Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event. It is alleged the patient experienced adhesions and infection. Adhesions are listed as a known possible adverse reaction in the instructions-for-use. In regards to infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ without a lot number a review of the manufacturing records could not be conducted. With the currently available information, no conclusion can be drawn. 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. Device not returned to manufacturer.

 
Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2015 - the patient underwent implant of a composix e/x mesh to treat a recurrent incisional hernia. On (b)(6) 2015 - the patient was allegedly diagnosed with "infected mesh" and required a subsequent surgery to remove the composix e/x. The surgeon excising the mesh alleged that the patient had "multiple adhesions to his abdominal wall," and performed lysis of adhesions allegedly caused by the composix e/x mesh. The attorney alleges the patient experienced infection, additional surgery, adhesions, permanent injury, defective mesh and explant.

 
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Brand NameCOMPOSIX 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
steven figueroa
100 crossings blvd.
warwick , RI 02886
4018258460
MDR Report Key6510854
Report Number1213643-2017-00264
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 04/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKAA015
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 Received03/29/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 04/21/2017 Patient Sequence Number: 1
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