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

Catalog Number	0117016
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Scar Tissue (2060); Seroma (2069); Impaired Healing (2378)
Date of Event	10/06/2016
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-feb-2016) 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 sepramesh ip (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) 2010 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with the implant of sepramesh ip (device #1).Per op notes, ¿extensive adhesions around the previous synthetic mesh have been tacted as well as several hernia defects around the mesh were noted.A sepramesh ip (device #1) was placed over the mesh through peritoneal cavity and tacked circumferentially.¿ on (b)(6) 2014 ¿ patient was diagnosed with nonhealing abdominal wound, infected abdominal mesh thereby underwent partial removal of mesh (device #1).Per op notes, ¿a large piece of bile-stained synthetic mesh with some purulent fluid was removed.Abscess were drained.A sepramesh ip (device #1) was completely adherent to the bowel.Area of bowel had eroded through mesh causing enterocutaneous fistula.A piece of infected mesh was removed and rest of mesh kept in place." on (b)(6) 2014 ¿ patient was diagnosed with chronic nonhealing anterior abdominal wall and enterocutaneous fistula abdominal wall thereby underwent open repair.Per op notes, ¿the skin graft was placed over the wound bed and suction was kept over the fistula to prevent succus spillage.¿ on (b)(6) 2015 ¿ patient was diagnosed with infected abdominal mesh, enterocutaneous fistula and large incisional hernia thereby underwent open repair with the removal of mesh (device #1).Per op notes, ¿the patient had a large skin grafted abdomen from previous mesh (device #1) infection and enterocutaneous fistula were excised.Extensive lysis of adhesions was done.Two small bowel resections were performed to taken down both the enterocutaneous fistulas.A biological mesh (sttartice) was placed underlay to cover the defect using sutures.¿ on (b)(6) 2016 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of bard soft mesh.Per op notes, ¿a superior portion of the hernia sac was fused to the biological mesh.Extensive lysis of adhesion was performed.Tar portion of the procedure was undertaken.The large bard soft mesh (device #2) was placed overlying the posterior sheath and transfixed to the anterior abdominal wall using sutures.¿ on (b)(6) 2016 ¿ patient was diagnosed with chronic draining abdominal wound thereby underwent evacuation of abdominal seroma.On (b)(6) 2016 ¿ patient had serous drainage and scar tissue was excised.On (b)(6) 2017 ¿ patient was diagnosed with chronic nonhealing sinus tract thereby underwent open repair.Per op notes, ¿sinus tract was excised.The mesh appeared well incorporated into the abdominal wall without any evidence of any infection or contamination of the mesh.¿.

• 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: 22380749
• Report Number: 1213643-2025-00550
• Device Sequence Number: 15811721
• Product Code: FTL
• UDI-Device Identifier: 00801741030932
• UDI-Public: (01)00801741030932(17)210128(10)HUAP0744
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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: 01/28/2021
• Device Catalogue Number: 0117016
• Device Lot Number: HUAP0744
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2016
• 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: 53 YR
• Patient Sex: Female