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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994)
Date of Event	05/20/2020
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-apr-2019) is considered to be a best estimate.This mdr represents bard soft mesh pre-shaped w/ keyhole (device #2).An additional supplemental emdr was submitted to represent the bard pre-shaped with keyhole 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: (b)(6) 2019 ¿ patient was diagnosed with indirect bilateral inguinal hernia, femoral hernia and umbilical hernia thereby underwent open repair with the implant of bard pre-shaped with keyhole mesh (right - device #1) & bard soft mesh pre-shaped w/ keyhole (left - device #2).Per operative notes, ¿on right, a large indirect hernia defect was identified.Floor was reinforced using bard pre-shaped with keyhole mesh (device #1), which secured to symphysis pubis using suture.On left, a small indirect hernia and femoral hernia was noted.A bard soft mesh pre-shaped w/ keyhole (device #2) was secured to pubic tubercle using sutures.An umbilical hernia was repaired using sutures.¿ (b)(6) 2020 ¿ patient was diagnosed with bilateral inguinal pain, recurrent direct right inguinal hernia, recurrent ventral hernia thereby underwent open repair with the implant of bard pre-shaped with keyhole mesh (right - device #3) for right inguinal hernia and bard flat mesh (device #4) for ventral hernia.Per operative notes, ¿on right, a recurrent hernia was noted.The ilioinguinal nerve and genitofemoral nerve encased in scar was amputated.The iliohypogastric nerve was found proximity to previous mesh was divided.A large pre-shaped with keyhole mesh (device #3) was placed and tacked to pubic symphysis.The recurrent ventral hernia was repaired using a bard flat mesh (device #4), which tacked to overlying tissue to abdominal wall circumferentially.In left groin, scar was encountered.Left iliohypogastric nerve and genitofemoral nerve were resected.¿.

• 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: 22749041
• Report Number: 1213643-2025-00740
• Device Sequence Number: 9672522
• Product Code: FTL
• UDI-Device Identifier: 00801741030925
• UDI-Public: (01)00801741030925(17)240428(10)HUDR0231
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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: 04/28/2024
• Device Catalogue Number: 0117015
• Device Lot Number: HUDR0231
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2019
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 92 KG