MAUDE Adverse Event Report: BARD SHANNON LIMITED 3005636544 BARD SOFT MESH; SURGICAL MESH

Catalog Number	0117011
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2017 - patient was diagnosed with bilateral direct inguinal hernia thereby underwent robotic assisted bilateral inguinal hernia repair with the implant of bard soft meshes (device #1 & #2) and was diagnosed with incisional hernia thereby underwent open repair with the implant of ventralex st (device #3).Per operative notes, "the hernia was identified and the peritoneum was taken down from the anterior abdominal wall.A right inguinal hernia was identified and reduced and a bard soft mesh (device #1) was anchored to cooper's ligament.A left inguinal hernia was identified and reduced into abdomen.Another bard soft mesh (device #2) anchored medially to cooper's ligament.The incisional hernia was seen and the defect was covered with a ventralex st (device #3) was placed and sutured." (b)(6) 2017 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with explant of ventralex st (device #3) and implant of ventrio st mesh (device #4).Per operative notes, "the previous mesh (device #3) noted with a recurrence inferiorly with preperitoneal fat.The mesh (device #3) was dissected off the fascia.The defect was seen and a ventrio st mesh (device #4) was secured and sutured.The mesh (device #4) was placed intra-abdominally." attorney alleges that the patient had pain, hernia recurrence, dissection of mesh and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 4 months post implant of bard soft mesh, patient was diagnosed with hernia recurrence thereby underwent medical intervention.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.A review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-dec-2016) is considered to be a best estimate.This supplemental emdr represents the bard soft mesh (device #1).An additional emdr was submitted to represent the bard soft mesh (device #2) and supplemental emdr was submitted to represent the ventralex st (device #3).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.

• Brand Name: BARD SOFT MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• 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: 21593333
• Report Number: 1213643-2025-090130
• Device Sequence Number: 18360068
• Product Code: FTL
• UDI-Device Identifier: 00801741030888
• UDI-Public: (01)00801741030888(17)211228(10)HUAZ0370
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• 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): 03/13/2025

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: 12/28/2021
• Device Catalogue Number: 0117011
• Device Lot Number: HUAZ0370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 93 KG