MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH; SURGICAL MESH

Catalog Number	0112650
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Rash (2033); Skin Burning Sensation (4540)
Date of Event	06/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, patient underwent a two-part procedure on (b)(6) 2021 which included a bilateral direct inguinal hernia repair with implant of a bard flat mesh cut into two pieces and used on both the right and left groin; a urolift system procedure for enlarged prostate with implant on non-bard/bd suture/metal implants.As reported about one year post implant patient started to experience a rash all over his legs, feet, and abdominal area around his umbilicus, experiencing excruciating pain on the bottom of his feet and skin burning.It was reported that the patient has had cellulitis on numerous occasions on his legs and feet.It was reported that the patient has undergone testing (ct scan and mirs) and as reported per patient's allergist, "patient developed a horrific rash that has not been responsive to any significant treatment since he had the mesh place.".
Additional Manufacturer Narrative
As reported, about 1-year post-implant of the flat mesh, patient had rash on legs, feet, abdomen, and pain in feet.Based on the information provided at this time, no conclusion can be made as to the degree to which the device, may be causing or contributing the patient¿s reported symptoms.A sample mesh has been provided for reactivity testing.The testing has not been scheduled at this time; we have requested the test results be provided once testing has been completed.When/if the results of the testing are provided a supplemental mdr will be submitted to document the results.Allergic reaction is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions for use, supplied with the device as a possible complication.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) released for distribution in oct 2020.Note, the date of event (18-jun-2022) is considered to be a best estimate based.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.
Additional Manufacturer Narrative
As reported, about 1-year post-implant of the flat mesh, patient had rash on legs, feet, abdomen, and pain in feet.Based on the information provided at this time, no conclusion can be made as to the degree to which the device, may be causing or contributing the patient¿s reported symptoms.A sample mesh has been provided for reactivity testing.The testing has not been scheduled at this time; we have requested the test results be provided once testing has been completed.When/if the results of the testing are provided a supplemental mdr will be submitted to document the results.Allergic reaction is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions for use, supplied with the device as a possible complication.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in oct 2020.Note, the date of event ((b)(6) 2022) is considered to be a best estimate based.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the reactivity test result.Reactivity testing has been performed and as reported the results were negative as there was no reaction to the mesh sample.It is unknown, what is causing the patient's condition.However, based on reactivity testing performed the flat mesh was not the cause of the reaction the patient experienced one year post implant.Updated fields: b4, d4, g3, g6, h2, h6, h10.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
As reported, patient underwent a two-part procedure on (b)(6) 2021 which included a bilateral direct inguinal hernia repair with implant of a bard flat mesh cut into two pieces and used on both the right and left groin; a urolift system procedure for enlarged prostate with implant on non-bard/bd suture/metal implants.As reported about one year post implant patient started to experience a rash all over his legs, feet, and abdominal area around his umbilicus, experiencing excruciating pain on the bottom of his feet and skin burning.It was reported that the patient has had cellulitis on numerous occasions on his legs and feet.It was reported that the patient has undergone testing (ct scan and mirs) and as reported per patient's allergist, "patient developed a horrific rash that has not been responsive to any significant treatment since he had the mesh place.".

• Brand Name: BARD FLAT MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 19625394
• Report Number: 1213643-2024-00335
• Device Sequence Number: 6360052
• Product Code: FTL
• UDI-Device Identifier: 00801741016509
• UDI-Public: (01)00801741016509(17)250828(10)HUEW1193
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: 08/28/2025
• Device Catalogue Number: 0112650
• Device Lot Number: HUEW1193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2020
• 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