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 Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	09/30/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2010 - patient had evisceration of previously repaired ventral hernia.The patient was in the operating room, began to cough very violently after being extubated resulting in hernia that was done with all of the stitches broken.An open repair was then performed with the implant of bard flat mesh (device #1, #2).Per operative notes, ¿then omentum was reduced into the abdominal cavity.The fascial ring was identified, and bard flat mesh (device #1, #2) was placed at the site with interrupted sutures.¿-13 (note: device #1, #2 have been considered based on the two implant stickers provided).(b)(6) 2015 - patient had recurrent incisional ventral hernia thereby underwent open repair with the implant of ventralight st mesh (device #3).Per operative notes, ¿the hernia bulge was opened and internal adhesions to the omentum were peeled away.There was some old mesh (device #1) in the inferior aspect of the repair site going down towards the umbilicus from a prior hernia repair.An oval sheet of ventralight st mesh (device #3) was then inserted into the abdominal cavity under the abdominal wall with the coated side down against the bowel using suture.¿ attorney alleges that the patient had adhesions, hernia recurrence, pain and suffering.And change in bowel habits after 2010 surgery, thinned out fascia.It was also alleged that about one year ago in 2017 patient had experienced abdominal pain, has not seen a doctor for it yet.Pain comes and goes.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 5 years 8 months post implant of bard flat mesh, patient was diagnosed with hernia recurrence & adhesions thereby underwent hernia repair.The instructions-for-use supplied with the device lists hernia recurrence & adhesions as possible complications.Addendum: h11: this supplemental emdr is submitted to correct the date of implant.Updated fields: b4, g3, g6, h2, h4 (manufacturing date), h10, h11.Corrected field: d.6a (date of implant).This supplemental emdr represents the bard flat mesh (device #2).An additional supplemental emdr was submitted to represent the bard flat mesh (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.
Event or Problem Description
Per information provided: (b)(6) 2010 - patient had evisceration of previously repaired ventral hernia.The patient was in the operating room, began to cough very violently after being extubated resulting in hernia that was done with all of the stitches broken.An open repair was then performed with the implant of bard flat mesh (device #1 , #2).Per operative notes, ¿then omentum was reduced into the abdominal cavity.The fascial ring was identified, and bard flat mesh (device #1, #2) was placed at the site with interrupted sutures.¿-13 (note: device #1, #2 have been considered based on the two implant stickers provided).(b)(6) 2015 - patient had recurrent incisional ventral hernia thereby underwent open repair with the implant of ventralight st mesh (device #3).Per operative notes, ¿the hernia bulge was opened and internal adhesions to the omentum were peeled away.There was some old mesh (device #1) in the inferior aspect of the repair site going down towards the umbilicus from a prior hernia repair.An oval sheet of ventralight st mesh (device #3) was then inserted into the abdominal cavity under the abdominal wall with the coated side down against the bowel using suture.¿ attorney alleges that the patient had adhesions, hernia recurrence, pain and suffering.And change in bowel habits after 2010 surgery, thinned out fascia.It was also alleged that about one year ago in 2017 patient had experienced abdominal pain, has not seen a doctor for it yet.Pain comes and goes.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 5 years 8 months post implant of bard flat mesh, patient was diagnosed with hernia recurrence & adhesions thereby underwent hernia repair.The instructions-for-use supplied with the device lists hernia recurrence & adhesions as possible complications.This emdr represents the bard flat mesh (device #2).An additional supplemental emdr was submitted to represent the bard flat mesh (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.

• 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: 21312493
• Report Number: 1213643-2025-090065
• Device Sequence Number: 8083860
• Product Code: FTL
• UDI-Device Identifier: 00801741016509
• UDI-Public: (01)00801741016509(17)130428(10)HUSC1043
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: 04/28/2013
• Device Catalogue Number: 0112650
• Device Lot Number: HUSC1043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2008
• 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: 43 YR
• Patient Sex: Male