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

Catalog Number 0010301

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

Patient Problems Hemorrhage/Bleeding (1888); Deformity/ Disfigurement (2360); Disability (2371)

Event Date 09/04/2019

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 disability, pain, bleeding and subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.Not returned.

Event Description

Per the attorney: on (b)(6) 2018 the patient was diagnosed with incarcerated incisional ventral hernia.On (b)(6) 2019 the patient underwent ventral incisional herniorrhaphy with implant of a small ventralex patch in the preperitoneal space to repair the hernia.On (b)(6) 2019 the patient was traveling and started to experience extreme pain and profuse bleeding in the abdominal area.The patient visited the er and was told that surgery was required to remove the mesh.On (b)(6) 2019 the patient underwent removal of mesh.Attorney alleges that the patient had mental and physical suffering from significant pain, disfigurement, injuries, pain and suffering and other damages.It is also alleged that the patient is at elevated risk of hernia recurrence following the removal of mesh.It is also alleged that the patient experienced emotional distress and the device was defective.

• 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: 11083522
• MDR Text Key: 224745271
• Report Number: 1213643-2020-11478
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024008
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0010301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability