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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 Date 01/01/2013
Event Type  Injury  
Event Description

The following was reported to davol by the patient's md: it is alleged the patient underwent repair of bilateral inguinal hernias using two 3d max mesh on an unspecified date and two years later in 2013 the patient presented to md (not the implanting surgeon) with an open wound just beneath the umbilicus which was draining purulent fluid. The patient underwent ct scan at which time a catheter was placed to drain fluid from the wound. Wound cultures revealed many gram positive bacteria. Md indicates the infection tracts down to both mesh which have become infected. Patient is being treated aggressively with antibiotics.

Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event. We have contacted the initial reporter to request additional information. It has been alleged that the patient developed and is currently being treated for infection. Without a lot number a review of the manufacturing records could not be conducted. Additionally, the mesh remains implanted. This mdr includes all patient, event, and device information davol has received to date. If additional information is obtained, a follow up mdr will be submitted. See mdr 1213643-2013-00570 for information related to the other 3d max mesh implant.

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Brand Name3D MAX MESH
Manufacturer (Section D)
warwick RI
Manufacturer (Section G)
lot #1, rd #3, km 79.7
san geronimo industrial park
humacao PR 00791
Manufacturer Contact
laura berg
100 crossing blvd
warwick , RI 02886
MDR Report Key3445896
Report Number1213643-2013-00571
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 09/30/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Catalogue NumberUNKAA001
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/30/2013
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

Date Received: 10/24/2013 Patient Sequence Number: 1