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

Catalog Number	0112650
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 1 years 4 months post implant of bard flat mesh, patient was diagnosed with hernia recurrence thereby underwent repair.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.Note, the manufacturing date (15-oct-2016) is considered to be a best estimate.This emdr represents bard flat mesh (device #3).An additional supplemental emdr was submitted to represent perfix plug (device #1).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: not returned.
Event or Problem Description
Per information provided: (b)(6) 2015 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1 & device #2).Per operative notes, ¿an old unknown mesh was completely removed.A large direct left inguinal hernia was identified.Then a large plug (device #1) was tacked to the cooper ligament and the onlay patch was placed over the top of the pubic tubercle.A large direct right inguinal hernia was identified.Then a plug (device #2) was tacked to the cooper ligament and an onlay patch was placed over the top of the pubic tubercle.¿ (b)(6) 2017 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of bard flat mesh (device #3) and removal of perfix plug (device #1).Per operative notes, ¿recurrent left inguinal hernia was identified.Then a perfix plug (device #1) was removed.A piece of marlex mesh (device #3) was placed over the top and secured by sutures.¿ (there was no visualization/mention of perfix plug (device #2)).(b)(6) 2018 - patient was diagnosed with recurrent left inguinal hernia thereby underwent robotic assisted laparoscopic repair.Per operative notes, ¿hernia defect was identified.Bard flat mesh (device #3) was identified and the defect was reinforced by using synthetic mesh." (there was no visualization/mention of perfix plug (device #2)).Attorney alleges that the patient had pain, hernia recurrence and emotional injuries.

• Brand Name: BARD FLAT MESH
• Common Device Name: 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: 20830965
• Report Number: 1213643-2024-094834
• Device Sequence Number: 21015129
• Product Code: FTL
• UDI-Device Identifier: 00801741016509
• UDI-Public: (01)00801741016509(17)211028(10)HUAX0025
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: 0112650
• Device Lot Number: HUAX0025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male