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

Catalog Number UNKAA086

Device Problems Defective Device (2588); Extrusion (2934)

Patient Problems Unspecified Infection (1930); Injury (2348); Disability (2371)

Event Date 04/15/2017

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol ventralex st device used to treat the patient. The patient's attorney alleges the patient underwent an additional surgery as a result of "extruding and infected mesh"; however, no medical records have been provided. 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. ¿ 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. Should additional information be provided a supplemental emdr will be submitted. Note: 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. Not returned.

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2015: the patient underwent surgery for implant of an unspecified bard/davol ventralex st. On (b)(6) 2017: the patient underwent surgery as a result of extruding and infected hernia mesh. As reported, the patient is making a claim for an adverse patient outcome against the bard/davol ventralex st. As reported, the attorney alleges general allegations regarding the bard/davol ventralex for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient. ¿.

• Brand Name: VENTRALEX ST
• 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: 7491686
• MDR Text Key: 107512899
• Report Number: 1213643-2018-01339
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKAA086
• 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: 04/24/2018
• 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: 05/07/2018 Patient Sequence Number: 1