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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3D MAX MESH

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DAVOL INC., SUB. C.R. BARD, INC. 3D MAX MESH Back to Search Results
Catalog Number UNKAA001
Event Type  Injury  
Event Description

The initial attorney report alleged pain, required substantial medical treatment, scarring, disfigurement and permanent injury, defective mesh. The following is based on the medical records provided by the pt's attorney: (b)(6) 2004: pt underwent repair of recurrent right flank incisional hernia and a left inguinal hernia with a bard 3d mesh. On (b)(6) 2004: pt admitted to hospital for fever of unk origin. On (b)(6) 2004: pt presented with shortness of breath, diagnosed with congestive heart failure. Further diagnosed with bacterial endocarditis with (b)(6).

 
Manufacturer Narrative

The device associated with this event was originally reported to davol as a recalled composix kugel mesh; therefore, davol originally reported this event to the fda in accordance with (b)(4). Subsequently, davol has received additional event info indicating that the associated event device is not a recalled composix kugel mesh; therefore we are submitting this mdr based on the additional info received. The info provided indicates that the pt was treated for a wound infection. While there is no indication that the mesh was the source of the infection, the warning section of the ifu 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. " there was no lot number included in the medical records provided; therefore a review of the mfg records could not be conducted. Additionally, no sample was returned for eval. Based on the review of the info currently available, no connection could be made between the adverse pt outcome and the davol product in question. If additional event and/or eval info is obtained, a f/u mdr will be submitted.

 
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Brand Name3D MAX MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
warwick RI
Manufacturer (Section G)
BARD SHANNON LTD.
lot #1, road #3, km 79.7
san geronimo industrial park
humacao PR 00791
Manufacturer Contact
anna smith
100 crossings blvd.
warwick , RI 02886
8005566756
MDR Report Key2562893
Report Number1213643-2012-00340
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Other
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 12/19/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA001
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received12/19/2007
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: 05/01/2012 Patient Sequence Number: 1
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