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

Catalog Number UNKAA030

Device Problems Material Erosion (1214); Defective Device (2588); Material Deformation (2976)

Patient Problems Adhesion(s) (1695); Erosion (1750); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention for mesh explant, erosion, hardening, adhesions, hernia recurrence, scarring, chronic pain and permanent injury; 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

Attorney alleges that the patient was implanted with an unspecified bard mesh (bard flat mesh) and three unspecified non bard/ davol meshes.As reported, the patient had a hernia and or/ recurrent hernias that required surgical intervention for repair.It is alleged that following the surgeries, the patient experienced pain in the abdominal region.It is alleged that the surgical operations to remove the eroded surgical mesh spanned considerable periods of time, and it is unclear whether the all of the remnants of the mesh systems had been removed.It is also alleged that the patient suffered debilitating injuries, including; mesh erosion, hardening, chronic pain and adhesions, which required and will continue to require healthcare services.It is alleged that the mesh systems were defective, had eroded and caused dense scarring.The patient had suffered and would continue to suffer chronic debilitating pain, severe and permanent injuries and experienced emotional distress.

• Brand Name: BARD FLAT MESH
• 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: 9917681
• MDR Text Key: 186722898
• Report Number: 1213643-2020-03203
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2020
• 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