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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 0115321
Event Date 12/12/2008
Event Type  Injury  
Event Description

Per online medwatch form submitted by patient who then forwarded to field assurance: in 2008, patient underwent bilateral laparoscopic inguinal hernia repairs with 3dmax mesh. Patient complained of severe pain and swelling throughout the post-operative period which he reported was worse on the right side. Approx five months later, patient underwent open bilateral mesh explant procedures and reports that surgeon noted that from examination of the mesh, it appeared as if the right hernia mesh had folded in its midsection and no longer covered the hernia defect. Patient reported from late 2008-2009, he suffered severe pain and currently experiences daily pain episodes.

 
Manufacturer Narrative

Currently, it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We will submit a follow up report when/if product is returned for evaluation or additional information becomes available. See mdr 1213643-2009-00129 for information related to the other 3d max mesh implanted in 2008.

 
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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 LIMITED
san geronimo industrial pk
lot# 1, road# 3, km 79.7
humacao PR 00791
Manufacturer Contact
lori laplume
100 crossings boulevard
warwick , RI 02886
4018258300
MDR Report Key1342998
Report Number1213643-2009-00128
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation PATIENT
Type of Report Initial
Report Date 02/13/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0115321
Device LOT NumberHUSC0624
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/13/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2008
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: 03/11/2009 Patient Sequence Number: 1
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