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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
Device Problem Insufficient Information (3190)
Patient Problems Cyst(s) (1800); Micturition Urgency (1871); Inflammation (1932); Seroma (2069); Reaction (2414)
Event Type  Injury  
Event Description

The following was reported to davol. In (b)(6) 2010, a pt underwent laparoscopic inguinal hernia repair on both sides with two 3dmax mesh. No initial post operative issues were observed or reported. In (b)(6) 2013, the pt returned to the hospital complaining of micturition (need to urinate). A ct san noted a cyst on the dorsal of the abdominal wall as well as seroma at the mesh location. In (b)(6) 2013, incision and drainage of the seroma was performed and an active inflammation was noted. The pt was reported to have done well follow this procedure. The pt presented again in (b)(6) 2013 with increased micturition. A ct-ivp showed no anomalies, however, the cyst previously observed had grown. At this time, in regards to the cyst no surgical intervention has taken place, however, laparoscopic fenestration is being considered. Additionally, being considered is reactivity testing with a sample of the mesh as surgeon questioned if the response could be a possible reaction to the mesh. At this time the course of treatment is unk.

Manufacturer Narrative

Based on the currently available info, we are unable to determine what part, if any the bard device may have caused or contributed to the reported pt issues. Seroma and inflammation are both known possible adverse events listed in the ifu. A mfg review was performed and found no evidence of a mfg related cause for the reported event. This mdr includes all pt, event and device info davol has received to date. If add'l info is obtained, a f/u mdr will be submitted. See mdr 1213643-2014-00043 for info 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 crossings blvd.
warwick, RI 02886
MDR Report Key3672051
MDR Text Key4343080
Report Number1213643-2014-00044
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberK081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device EXPIRATION Date04/30/2014
Device Catalogue Number0115310
Device LOT NumberHUUC0655
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/03/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 02/25/2014 Patient Sequence Number: 1