MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Bard Soft Mesh; Surgical Mesh

Catalog Number	0117010
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Nerve Damage (1979); Scar Tissue (2060); Hernia (2240)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2018- patient was diagnosed with symptomatic left inguinal hernia thereby underwent laparoscopic repair with implant of bard soft mesh (device 1) and a synthetic mesh.Per op notes, "an incision was made to the subcutaneous tissue and extended until the anterior rectus sheath was encountered.A large indirect inguinal hernia was identified.On the right-side, a small to moderate sized inguinal hernia was identified and reduced.There was no direct hernia identified.A synthetic mesh was placed, aligned from the asis to mid of the pubis and secured with tacks to the cooper¿s ligament.On the left side, a bard soft mesh (device 1) was placed and aligned from the asis to mid of the pubis and secured with tacks.Both the meshes were positioned posterior and lateral to the peritoneum and the fascia of the anterior rectus was closed with sutures." (b)(6) 2023- patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with implant of bard soft mesh (device 2).Per op notes, "a left inguinal incision was made.The fascia was opened to the external ring.Scarring from the previous procedure and previous inguinal scar was identified.Residual hydrocele sac was excised.The hernia sac was opened, trimmed and reduced.The previously placed bard soft mesh (device 1) provided strength to area of conjoined tendon in the part of closure.Another bard soft mesh (device 2) was placed in the lacunar ligament and to the pubic tubercle and was secured with sutures.An ilioinguinal neurectomy was also performed.".
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-mar-2015) is considered to be a best estimate.This emdr represents the bard soft mesh (device 1).An additional supplemental emdr was submitted to represent the bard soft mesh (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.

• Brand Name: Bard Soft 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 ; +1(800)556-6756
• MDR Report Key: 50273984
• Report Number: 1213643-2026-01045
• Device Sequence Number: 18786091
• Product Code: FTL
• UDI-Device Identifier: 00801741030871
• UDI-Public: (01)00801741030871(17)200228(10)HUZC0628
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: 02/28/2020
• Device Catalogue Number: 0117010
• Device Lot Number: HUZC0628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2015
• 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: Disability; Required Intervention
• Patient Sex: Male