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

Catalog Number	0112660
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2018 ¿ patient was diagnosed with bilateral inguinal hernia and midline incisional hernia thereby underwent bilateral laparoscopic inguinal repair and open incisional hernia repair with implant 3dmax mesh- right (device #1) and 3dmax mesh - left (device #2) and bard flat mesh (device #3).Per operative notes, ¿the right direct hernia was identified, dissected and placed with 3dmax mesh (device #1) and in left side the indirect inguinal hernia was identified and repaired using 3dmax mesh (device #2).The midline incisional hernia sac was identified and dissected down to the level of fascia and bard flat mesh (device #3) was placed closed with staples.¿ (b)(6) 2019 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of bard flat mesh (device #4).Per operative notes, ¿the hernia sac was identified and dissected down to the level of fascia and bard flat mesh (device #4) was placed and sutured.¿ (b)(6) 2020 - patient was diagnosed with upper abdominal pain and upper abdominal adhesions thereby underwent laparoscopic adhesiolysis.Per operative notes, ¿the numerous omental adhesions to the upper abdominal wall were dissected away¿.
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.This emdr represents the bard flat mesh (device #3).An additional supplemental emdr was submitted to represent the bard/davol 3dmax mesh -left (device #2) and additional supplemental emdr was submitted to represent the bard/davol bard flat mesh (device #4) note, the manufacturing date (15-mar-2018) is considered to be a best estimate.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 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 ; 4018258495
• MDR Report Key: 22076028
• Report Number: 1213643-2025-090211
• Device Sequence Number: 18490337
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516(17)230328(10)HUCQ2319
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 05/23/2025

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: 03/28/2023
• Device Catalogue Number: 0112660
• Device Lot Number: HUCQ2319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2018
• 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: 71 YR
• Patient Sex: Female