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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 00000000
Device Problem Insufficient Information (3190)
Patient Problem Obstruction/Occlusion (2422)
Event Type  Injury  
Event Description

In 2009, approx two years ago, pt underwent hernia repair with 3dmax mesh implanted. It was reported the pt "later" developed bowel obstruction.

Manufacturer Narrative

Based on the info currently available, it is unk whether the device may have caused or contributed to the event. The physician indicated that the device may not have been used in accordance with the ifu. Additionally, no product has been returned. No conclusion can be drawn at this time. Available info indicates no device will be returned and/or add'l info will be provided. We therefore, consider this report complete to the best of our current knowledge.

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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
anna smith
100 crossing blvd.
warwick, RI 02886
MDR Report Key2120432
MDR Text Key2056209
Report Number1213643-2011-00256
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NO INFORMATION
Type of Report Initial
Report Date 05/13/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Catalogue Number00000000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Hospital
Date Manufacturer Received05/13/2011
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: 06/03/2011 Patient Sequence Number: 1