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

Catalog Number 0010302

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Pain (1994); Hernia (2240); Insufficient Information (4580)

Event Date 02/06/2015

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, chronic pain, and revision surgery. The instructions-for-use supplied with the device lists hernia recurrence and inflammation as possible complications. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be provided, a supplemental emdr will be submitted. Not returned.

Event Description

Attorney alleges that on or about (b)(6) 2013, the patient underwent repair of an abdominal hernia and was implanted with a bard/davol ventralex mesh and a non-bard mesh. It is alleged that "as a direct and proximate result of defendants¿ defective design, manufacture, marketing, distribution, and/or sale of the ventralex and proceed and placing the defective product into the stream of commerce, the patient has been injured and damaged as follows": on or about (b)(6) 2015, the patient underwent revision of the ventralex mesh and the non bard/davol mesh. It is alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, mesh detachment, mesh reinforcement, and recurrence. It is alleged that the patient continues to suffer complications as a result of implantation with the bard/davol ventralex and non bard/davol mesh. It is alleged that the patient is at higher risk of severe complications during an abdominal surgery. It is alleged that the patient has suffered and will continue to suffer physical pain and suffering, as well as mental anguish and emotional distress. It is also alleged that the patient have been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, impairment. Attorney alleges "past, present, and future damages, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by the patient and permanent impairment. ".

• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 14533661
• MDR Text Key: 293341961
• Report Number: 1213643-2022-94185
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/28/2018
• Device Catalogue Number: 0010302
• Device Lot Number: HUXC1466
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2013
• 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: 05/28/2022 Patient Sequence Number: 1