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

Catalog Number	0112640
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Nerve Damage (1979); Neuralgia (4413)
Date of Event	12/19/2011
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 year 8 months post implant of bard flat mesh, patient was diagnosed with nerve damage and neuralgia thereby underwent repair.This emdr represents bard mesh (bard flat mesh) (device #3).An additional supplemental emdr's was submitted to represent bard/davol perfix plug (device #1) and perfix plug (device #2).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 by patient's attorney: 29-jan-2008 - patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1).Per operative notes, ¿the hernia was identified and reduced through internal ring.A small perfix plug (device #1) was placed into the external ring and into inguinal canal and sutured.¿ 23-mar-2009 - patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #2).Per operative notes, ¿the direct inguinal hernia was identified and reduced.A perfix plug (device #2) was placed and sutured.¿ (note: there was no visualization of previous mesh).(b)(6) 2010 - patient was diagnosed with right groin pain thereby underwent repair with removal of meshes and implant of bard flat mesh (device #3).Per operative notes, ¿ilioinguinal and iliohypogastric nerves were identified and divided.The ilioinguinal nerve had gone into the scar tissue.The wadded piece of polypropylene mesh (device #1 & device #2) were freed and removed.A bard flat mesh (device #3) was placed and sutured.¿ 19-dec-2011 - patient was diagnosed with chronic left groin pain with nerve entrapment syndrome thereby underwent left groin exploration with ilioinguinal neurectomy.10-sep-2014 - patient was diagnosed with left groin pain due to left ilioinguinal/iliohypogastric neuralgia thereby underwent repair.Attorney alleges that the patient had adhesions, mesh shrinkage, nerve damage, pain, hernia recurrence and also alleged that need for additional surgeries to remove or repair.

• 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: 18509308
• Report Number: 1213643-2024-090059
• Device Sequence Number: 7811336
• Product Code: FTL
• UDI-Device Identifier: 00801741016493
• UDI-Public: (01)00801741016493
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 01/12/2024

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: 09/28/2014
• Device Catalogue Number: 0112640
• Device Lot Number: HUTI0636
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Disability; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 73 KG