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

Catalog Number UNKAA086

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

Patient Problems Pain (1994); Injury (2348); Disability (2371)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made. The patient's attorney alleges "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"; however, no details have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. This emdr represents the bard/davol ventralex st (device #2). Additional emdrs were submitted to represent the bard/davol mesh - ventralex (device #1), the bard/davol ventrio st (device #3) and the bard/davol ventralight st mesh (device #4). Should additional information be provided, a supplemental emdr will be submitted. Not returned.

Event Description

Attorney alleges that the patient underwent surgery for the implant of unspecified bard/davol ventralex, ventralex st, ventrio st and ventralight st on (b)(6) 2007 and/or (b)(6) 2016 and/or (b)(6) 2018. As reported, the patient is making a claim for an adverse patient outcome against all devices. It is alleged that the patient sustained injuries on (b)(6) 2018. Attorney alleges general allegations 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. " it is also alleged that the patient experienced emotional distress and the device was defective.

• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 11294676
• MDR Text Key: 230776731
• Report Number: 1213643-2021-00938
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• 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?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/26/2021
• 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: 02/08/2021 Patient Sequence Number: 1