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

Catalog Number	0117011
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Hernia (2240)
Date of Event	04/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2010: patient was diagnosed with recurrent incarcerated left inguinal hernia thereby underwent open repair with the implant of perfix plug mesh (device #1).Per operative notes, ¿a perfix plug mesh (device #1) was placed and sutured.¿ on (b)(6) 2017: patient was diagnosed with recurrent left inguinal hernia, right indirect inguinal hernia thereby underwent a laparoscopic repair with implant of bard soft mesh (left side ¿ device #2) and right-side bard soft mesh (device #3, device #4).Per operative notes, ¿on left side one bard soft mesh (device #2) was placed and sutured.On right side hernia sac was dissected.Two bard soft mesh (device #3, device #4) was placed and sutured.¿ on (b)(6) 2018: patient was diagnosed with left post hernia inguinodynia, pain, scar tissue thereby underwent open repair with explant of perfix plug mesh (device #1) and bard soft mesh (device #2).Per operative notes, ¿scar tissues were divided.Perfix plug mesh (device #1) and bard soft mesh (device #2) was excised completely.¿ on (b)(6) 2018: patient was diagnosed with deep groin pain thereby underwent repair with nerve block, placed fentanyl, gabapentin, and hydrocodone for pain relief.(note: no ae found regarding implanted mesh).On (b)(6) 2018: patient was diagnosed with left lower quadrant pain; right lower quadrant pain thereby underwent repair with bilateral ilioinguinal nerve block.On (b)(6) 2019: patient was diagnosed with left lower quadrant pain; right lower quadrant pain thereby underwent repair with bilateral ilioinguinal nerve block.
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-dec-2015) is considered to be a best estimate.This emdr represents the bard soft mesh (device #2).An additional supplemental emdr was submitted to represent the bard perfix plug (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.

• 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 ; 8005566756
• MDR Report Key: 22531898
• Report Number: 1213643-2025-00647
• Device Sequence Number: 7410273
• Product Code: FTL
• UDI-Device Identifier: 00801741030888
• UDI-Public: (01)00801741030888(17)201228(10)HUZL1000
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/04/2025

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: 12/28/2020
• Device Catalogue Number: 0117011
• Device Lot Number: HUZL1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2015
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male