MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH; SURGICAL MESH

Catalog Number UNKAA030

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Obstruction/Occlusion (2422)

Event Date 06/15/2015

Event Type  Injury  

Manufacturer Narrative

Based on the information reported, no conclusions can be made.The information provided is limited.Multiple attempts were made requesting additional information, however, there has been no response.Infection is a known inherent risk of surgery.The warning section of the instructions-for-use, supplied with the device states, ¿if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.¿ an unresolved infection may require removal of the device." no lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of implant and date of event was estimated as (b)(6) 2015 based on the available information.

Event Description

The following was reported, "in 2015, tests were performed, mesh (flat mesh) was put in.Soreness in the stomach.Bowel restrictions, tenderness/soreness in whole abdominal area.Stomach infections found on numerous occasions.Daily pain.Lymph node appeared, surgery to have it removed.Both nerves were taken out during the surgery, hoping to alleviate the pain -- unsuccessful.Mesh causes internal problems, told that there were potential consequences (potential losing life) upon removal".

• Brand Name: BARD FLAT MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 15811093
• MDR Text Key: 303796928
• Report Number: 1213643-2022-00735
• 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: Other,Consumer,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2022
• 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): Required Intervention
• Patient Sex: Male