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

Catalog Number UNKAA030

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Pain (1994); Hernia (2240)

Event Date 04/07/2015

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges hernia recurrence, abscess, subsequent surgical intervention and "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.The instructions-for-use (ifu) supplied with the device lists hernia recurrence as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.In regard to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." this emdr represents the bard flat mesh (device #1).Additional emdrs were submitted to represent the bard flat mesh (device #2) and the bard soft mesh (device #3).Should additional information be provided, a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that the patient underwent abdominoplasty repair on (b)(6) 2014 and repair of abdominal wall abscess and laparotomy on (b)(6) 2014.It is alleged that the patient underwent ventral hernia repair on (b)(6) 2015 with an unspecified bard mesh (bard flat mesh).It is also alleged that the patient underwent ventral hernia repair with "old mesh" on (b)(6) 2015 and abdominal wall abscess repair on (b)(6) 2019.Attorney further alleges that the patient underwent herniorrhaphy repair with an unspecified bard mesh (bard flat mesh) on (b)(6) 2019 and implant of a bard soft mesh on (b)(6) 2019.As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the device was defective.

• 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: 12981755
• MDR Text Key: 282100998
• Report Number: 1213643-2021-09235
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2021
• 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: 12/03/2021
• 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; Required Intervention
• Patient Sex: Female