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

Catalog Number 0112680

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

Patient Problems Internal Organ Perforation (1987); Pain (1994); Disability (2371)

Event Date 02/09/2000

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.It is unknown to what extent the bard/davol bard flat mesh (device #1) device may have caused or contributed to the events as alleged by the patient¿s attorney.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.This emdr represents the bard/davol bard flat mesh (device #1).An additional emdr was submitted to represent the bard/davol bard flat mesh (device #2).The patient's attorney did not make any allegations regarding the implanted bard/davol allomax device.Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

As reported, per medical records: (b)(6) 1999: the patient underwent repair of a vaginal prolapse with placement of a bard/davol flat mesh (device #1) - vaginal.On (b)(6) 2000: the patient underwent an examination under anesthesia, excision of a pedunculated polypoid hemorrhoidal skin tag 3x3cm, exploration of the right lower quadrant, incisional mass, hematoma, serosa with necrotic fat complex and excision of this complex repair in layers, exploration and excision of umbilical and epigastric hernias with reinforcement with implant of a bard/davol "marlex" davol flat (device #2) and placement of a jackson-pratt fluted drain to prevent seroma formation.On (b)(6) 2010: the patient was diagnosed with a right lower quadrant incisional hernia, recurrent midline incisional hernia, infected mesh graft (device #2) due to a chronic skin wound at the umbilicus and underwent a laparoscopy, laparotomy, removal of the bard/davol flat mesh (device #2), and implant of a bard/davol allomax biologic graft.

• 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: roxanne tidwell ; 100 crossings blvd.; warwick, RI 02886 ; 8015652300
• MDR Report Key: 9009035
• MDR Text Key: 157810751
• Report Number: 1213643-2019-08670
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2004
• Device Catalogue Number: 0112680
• Device Lot Number: 43FJD181
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/1999
• 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
• Patient Age: 48 YR
• Patient Weight: 143