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

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.

• 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: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 3672051
• MDR Text Key: 4343080
• Report Number: 1213643-2014-00044
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: NL
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• 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 Received: 02/25/2014
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 04/30/2014
• Device Catalogue Number: 0115310
• Device LOT Number: HUUC0655
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Date Manufacturer Received: 02/03/2014
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/01/2010
• 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: 02/25/2014 Patient Sequence Number: 1