MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD SOFT MESH PRE-SHAPED W/ KEYHOLE; SURGICAL MESH

Catalog Number	0117015
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Hernia (2240)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
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-jun-2018) is considered to be a best estimate.This mdr represents the bard soft mesh pre-shaped with keyhole (device 3).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: on (b)(6) 2019 ¿ patient was diagnosed with bilateral inguinal hernia and umbilical hernia thereby underwent laparoscopic repair with implant of two bard flat meshes (device 1 and 2).Per operative notes, ¿the peritoneum was mobilized and two indirect inguinal hernia sacs on right and left sides were identified and reduced.Two bard flat meshes (device 1 and 2) were placed within peritoneal space bilaterally and fascia was closed.To the small umbilical defect, the fascial defect was reduced and closed with sutures circumferentially.¿ on (b)(6) 2019 - patient was diagnosed recurrent left inguinal hernia and pain thereby underwent open repair with implant of bard soft mesh pre-shaped with keyhole (device 3).Per operative notes, ¿in the left groin, the hernial defect was reduced and a piece of bard soft mesh pre-shaped with keyhole (device 3) was placed in the inguinal canal and secured the mesh with sutures.¿ on (b)(6) 2020 ¿ patient was diagnosed with left groin pain, thereby underwent laparoscopic repair with left groin exploration and removal of meshes (device 1 and 3).Per operative notes, ¿the left inguinal meshes (device 1 and 3) were significantly scarred and folded over itself.The meshes (device 1 and 3) were dissected circumferentially and excised.The fascia was closed and secured with sutures.¿.

• Brand Name: BARD SOFT MESH PRE-SHAPED W/ KEYHOLE
• 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: 24468281
• Report Number: 1213643-2026-00248
• Device Sequence Number: 18537188
• Product Code: FTL
• UDI-Device Identifier: 00801741030925
• UDI-Public: (01)00801741030925(17)230528(10)HUCT0948
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: 05/28/2023
• Device Catalogue Number: 0117015
• Device Lot Number: HUCT0948
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2018
• 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: 37 YR
• Patient Sex: Male