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 Problem Discomfort (2330)

Event Date 06/15/2005

Event Type  malfunction  

Manufacturer Narrative

As reported, post-implant of the marlex mesh, the patient has experienced discomfort.The information provided was limited and did not categorize the level of discomfort or if any treatment had been provided.Based on the information provided to date, no conclusion can be made.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 (15-jun-2005) are provided as a best estimate based on the available information.Not returned - remains implanted.

Event Description

As reported, during a hernia repair procedure in 2005, the patient was implanted with marlex mesh.As reported, the patient has been suffering discomfort for a long time and enquired if the discomfort could be related to the application of the mesh.

• 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: 15169164
• MDR Text Key: 297428443
• Report Number: 1213643-2022-00569
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2022
• 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): Other