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

Catalog Number	0117010
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2018 - patient was diagnosed with peristomal hernia thereby underwent open repair with the implant of ventralex st mesh (device 1) and bard soft mesh (device 2).Per operative notes, ¿the hernia sac was removed.A ventralex st mesh (device 1) and bard soft mesh (device 2) was placed into the right abdomen and secure it with sutures.¿ on (b)(6) 2019 - patient was diagnosed with recurrent peristomal hernia, bowel obstruction, adhesion thereby underwent open repair with implant of ventralex st mesh (device 3) and ventralight st mesh (device 4).Per operative notes, ¿right side of the abdomen there was a parastomal hernia sac.Hernia sac was dissected out.Previously placed ventralex st mesh (device 1) and bard soft mesh (device 2) was intact.A ventralex st mesh (device 3) and ventralight st mesh (device 4) was placed into the right abdomen together and secure it with sutures.¿ on (b)(6) 2019 - patient was diagnosed with abdominal wound, ventral hernia bowel obstruction thereby underwent repair with abdominal washout and wound vac placement and implant of bard soft mesh (device 5).Per operative notes, ¿hernia sac was dissected out.A bard soft mesh (device 5) was placed and secure it with 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-nov-2017) is considered to be a best estimate.This emdr represents the bard soft mesh (device 2).Additional supplemental emdrs were submitted to represent two bard ventralex st (device 1 and 3) and bard ventralight st mesh (device 4).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: 23026153
• Report Number: 1213643-2025-00828
• Device Sequence Number: 9682207
• Product Code: FTL
• UDI-Device Identifier: 00801741030871
• UDI-Public: (01)00801741030871(17)221228(10)HUBY1644
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• 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): 09/09/2025

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: 12/28/2022
• Device Catalogue Number: 0117010
• Device Lot Number: HUBY1644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2017
• 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: 61 YR
• Patient Sex: Female