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

Catalog Number 00000000

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.

• Brand Name: 3D MAX MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED; lot#1, rd#3, km 79.7; san geronimo industrial park; humacao PR 00791
• Manufacturer Contact: anna smith ; 100 crossing blvd.; warwick , RI 02886 ; 8005566756
• MDR Report Key: 2120432
• Report Number: 1213643-2011-00256
• Device Sequence Number: 1
• Product Code: FTL
• 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 Received: 06/03/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 00000000
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/13/2011
• 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

Patient TREATMENT DATA

Date Received: 06/03/2011 Patient Sequence Number: 1