MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH-VENTRALEX SURGICAL MESH

Catalog Number UNKAA077

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

Patient Problems Unspecified Infection (1930); Hernia (2240); Disability (2371)

Event Date 09/01/2010

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient. The patient's attorney did not allege a specific device failure and no medical records have been provided. Based on the limited information provided at this time, no conclusions can be made. No lot number has been provided; therefore a review of the manufacturing records is not possible at this time. Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication. Regarding infection the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ should additional information be provided a supplemental emdr will be submitted. Not returned.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2007: the patient underwent surgery for repair of an umbilical hernia and was implanted with a bard/davol ventralex hernia patch. (b)(6) 2010: the patient underwent an additional surgery to remove the infected mesh and repair the umbilical hernia. As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective ventralex hernia patch.

• Brand Name: MESH-VENTRALEX
• 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: francesca santamaria ; 100 crossings blvd.; warwick, RI 02886 ; 4018258538
• MDR Report Key: 7142847
• MDR Text Key: 95642539
• Report Number: 1213643-2017-01101
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKAA077
• 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: 12/05/2017
• 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: 12/22/2017 Patient Sequence Number: 1