MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX; SURGICAL MESH

Catalog Number UNKAA001

Device Problems Entrapment of Device (1212); Defective Device (2588); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Insufficient Information (4580)

Event Type  Injury  

Event Description

Attorney alleges that on or about (b)(6) 2009, the patient was implanted with a bard/davol 3dmax mesh.It is alleged that the patient has undergone and continues to suffer severe pain caused by the device and the patient needs the device surgically removed.It is alleged that "the product mesh was defective in many ways; mainly it was defectively designed and manufactured which allowed patient's nerves and muscles to become intertwined in the mesh causing excruciating pain, permanent injury and disfigurement".It is alleged that the patient was injured and has suffered certain permanent and personal injuries, including but not limited to, excruciating mental and physical pain and suffering and permanent impairment to the whole body.

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 pain, disfigurement and permanent injury.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.

• Brand Name: 3DMAX
• 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: 14739721
• MDR Text Key: 294940730
• Report Number: 1213643-2022-94801
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081010
• 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: 06/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/18/2022
• 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): Disability
• Patient Sex: Male