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

Catalog Number	0117009
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hernia (2240)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2013 - patient was diagnosed with incisional ventral hernia thereby underwent open repair with the implant of bard flat mesh (device 1).Per op notes, "a midline incision was made from above the umbilicus down to below the umbilicus over the hernia sac.A bard flat mesh (device 1) was sutured to the fascia using prolene sutures." (b)(6) 2013 - patient had sepsis.(b)(6) 2014 - patient was diagnosed with recurrent incisional ventral hernia thereby underwent open repair with the removal of mesh (device 1) and implant of bard soft mesh (device 2).Per op notes, "midline incision made through the previous scar.Removal of the old mesh (device 1) from the umbilical area, a bard soft mesh (device 2) was sutured to the rectum sheath using prolene sutures." (b)(6) 2020 - patient was diagnosed with recurrent incisional ventral hernia and had abdominal pain thereby underwent open repair with the implant of phasix st (device 3).Per op notes, "incision was carried down through subcutaneous tissue to where the mesh and fascia was located.A phasix st (device 3) was placed using sutures.".
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-feb-2013) is considered to be a best estimate.This mdr represents the bard soft mesh (device 2).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.

• 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: 24457024
• Report Number: 1213643-2026-00234
• Device Sequence Number: 10148231
• Product Code: FTL
• UDI-Device Identifier: 00801741030864
• UDI-Public: (01)00801741030864(17)180328(10)HUXB1614
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2026

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: 03/28/2018
• Device Catalogue Number: 0117009
• Device Lot Number: HUXB1614
• 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: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2013
• 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: 49 YR
• Patient Sex: Female