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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 0115310
Event Date 10/19/2009
Event Type  Injury  
Event Description

Pt reports pain and bulging on left side at hernia repair site following implant of two (2) meshes on left side during lap inguinal repair 2007. In 2009- pt underwent exploratory surgery, during which a recurrent hernia was confirmed. Pt stated that the surgeon had indicated that one of the mesh patches implanted in 2007, had shifted a little due to a recurrence. Surgeon placed a perfix plug to correct the condition. Original meshes implanted in the same month, were left in place.

 
Manufacturer Narrative

Currently, it is unk whether or not the device may have caused or contributed to the event as no product has been returned and we are unable to determine cause of the mesh "shifting". While recurrence is a known adverse event that is listed in the ifu, no conclusion can be drawn at this time. Additionally we are unable to determine which of the two 3d max mesh implanted in 2007 "shifted", therefore, we are reporting both mesh implants. See mdr 1213643-2009-00456 for info related to the other 3d max mesh implanted in the same month.

 
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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
san geronimo indus pk
lot#1, rd#3, km 79.7
humacao PR 00791
Manufacturer Contact
lori laplume
100 crossing blvd
warwick , RI 02886
MDR Report Key1519799
Report Number1213643-2009-00456
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 10/12/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/30/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0115310
Device LOT NumberHURC8804
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received10/28/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2007
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: 10/30/2009 Patient Sequence Number: 1
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