MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX SURGICAL MESH

Model Number 0115320

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Pain (1994); Hernia (2240); Disability (2371)

Event Date 05/16/2008

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. The information provided alleges that the, "patient underwent an additional surgery to repair the hernia defect and remove it. " medical records were not provided and the description does not clearly define what "remove it" is referring to (example possible mesh explant, partial explant, or removal/repair of the hernia defect itself without explant of previously placed mesh). As such at this time, we have not identified this as reported device explant. It is unclear at this time if the hernia defect repaired post implant of the mesh was a recurrence of the original hernia defect or a new hernia defect, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2006 - the patient underwent surgery for repair of a right inguinal hernia, a bard/davol 3dmax mesh was implanted to repair the hernia defect. On (b)(6) 2008 - the patient underwent an additional surgery to repair the hernia defect and remove it. The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.

• Brand Name: 3DMAX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 7153875
• MDR Text Key: 96014143
• Report Number: 1213643-2017-01136
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/28/2009
• Device Model Number: 0115320
• Device Catalogue Number: 0115320
• Device Lot Number: 43CQD475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2006
• 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: 12/29/2017 Patient Sequence Number: 1