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

Catalog Number	0117011
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Bowel Perforation (2668)
Date of Event	06/14/2013
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-jun-2012) is considered to be a best estimate.This mdr represents the bard soft mesh (device #3).An additional supplemental mdr was submitted to represent the bard flat mesh (device #1) and additional mdr's were submitted to represent ventralight st mesh (device #2), ventrio st (device #4), ventrio st (device #5).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: (b)(6) 2007- patient was diagnosed with incisional hernia thereby underwent open repair with the implant of bard flat mesh (device #1).Per operative notes, ¿a bard flat mesh (device #1) was placed and sutured.¿ (b)(6) 2012 - patient was diagnosed with incisional hernia thereby underwent open repair with explant of bard flat mesh (device #1) and implant of ventralight st mesh (device #2) and bard soft mesh (device #3).Per operative notes, ¿old bard flat mesh (device #1) was excised.One ventralight st mesh (device #2) and one bard soft mesh (device #3) was placed and sutured.¿ (b)(6) 2013 - patient was diagnosed with intestinal perforation, adhesion, abscess, mesh infection, inflammation thereby underwent open repair with explant of ventralight st mesh (device #2) and bard soft mesh (device #3), lysis of adhesion, abscess, and implant one synthetic mesh.Per operative notes, ¿abscess were drained from intra-abdominal area.Infected ventralight st mesh (device #2) and bard soft mesh (device #3) was excised completely.¿ (b)(6) 2014 - patient was diagnosed with ventral incisional hernia, adhesion thereby underwent open repair with explant old biological mesh and implant two ventrio st mesh (device #4) and ventrio st mesh (device #5).Per operative notes, ¿all adhesions were taken down.Old synthetic mesh was excised.Two ventrio st mesh (device #4) and ventrio st mesh (device #5) was placed and sutured.¿ (b)(6) 2019 - patient was diagnosed with small bowel obstruction, adhesion thereby underwent open repair with lysis of adhesion and explant of ventrio st mesh (device #4) and ventrio st mesh (device #5).Per operative notes, ¿ventrio st mesh (device #4) and ventrio st mesh (device #5) which was several pieces were all removed from abdominal wall.All adhesions were taken down.¿.

• 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: 22492563
• Report Number: 1213643-2025-00624
• Device Sequence Number: 7940287
• Product Code: FTL
• UDI-Device Identifier: 00801741030888
• UDI-Public: (01)00801741030888(17)170728(10)HUWF2495
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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: 07/28/2017
• Device Catalogue Number: 0117011
• Device Lot Number: HUWF2495
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2012
• 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