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	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	08/20/2020
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-oct-2018) is considered to be a best estimate.This emdr represents the bard/davol soft mesh (device #2).An additional supplemental emdr was submitted to represent the bard/davol ventralight st (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 additional information provided: on (b)(6) 2019 - patient was diagnosed with multiple recurrent ventral hernia thereby underwent robotic repair with implant of ventralight st mesh (device 1).Per op notes, ¿an left subcoastal incision was made.Recurrent ventral hernia with the mesh separated from the left superior side was noted.Most of the prior mesh was well incorporated but the part near the recurrence was free and removed.Then underlay repair was performed by placing a ventralight st mesh (device 1) facing the abdominal viscera and secured to the fascia with suture.¿ (note: the prior mesh visualized during this procedure was unknown) on (b)(6) 2019 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with excision of ventralight st mesh (device 1) and implant of bard soft mesh (device 2).Per op notes, ¿the previous midline wound was opened.Adhesions to the anterior abdominal wall were freed.The prior mesh (device 1) was removed.Seprafilm was placed under the abdominal closure.The abdominal wall was then closed with sutures.A bard soft mesh (device 2) was placed and secured to the fascia with suture.¿ on (b)(6) 2020 - patient was diagnosed with incarcerated recurrent ventral hernia thereby underwent open repair with excision of bard soft mesh (device 2) and implant of synthetic mesh.Per op notes, ¿midline incision was made over the previous incision.Umbilical stalk was then detached.The hernia sac was excised and a knuckle of bowel was significantly adhesed to the previously placed mesh (device 2).The small bowel was dissected free from the mesh.Some localized adhesions to the small bowels were taken down and this was reduced.Majority of the previously placed mesh (device 2) was removed.A synthetic mesh was placed and secured with sutures.¿.

• 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: 24813428
• Report Number: 1213643-2026-00449
• Device Sequence Number: 6011629
• Product Code: FTL
• UDI-Device Identifier: 00801741030864
• UDI-Public: (01)00801741030864(17)231028(10)HUCX2384
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: 10/28/2023
• Device Catalogue Number: 0117009
• Device Lot Number: HUCX2384
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2018
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 83 KG