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	Pain (1994); Hernia (2240)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2002 ¿ patient was diagnosed with umbilical hernia thereby underwent open repair with implant of perfix plug (device 1).Per operative notes, ¿the umbilical hernia sac was dissected off the surrounding structures and medium perfix plug (device 1) was placed and sutured.¿ on (b)(6) 2009 ¿ patient was diagnosed with recurrent umbilical hernia thereby underwent laparoscopic repair with removal of previously placed mesh (device 1) and implant of synthetic mesh.Per operative notes, ¿the omentum was adherent to the umbilical defect and mesh (device 1) was seen rolled and scarred to edge of the hernia defect.The hernia sac and mesh (device 1) was dissected, and hernia defect was repaired with synthetic mesh then sutured and tacked.¿ on (b)(6) 2018 ¿ patient was diagnosed with recurrent incisional hernia and pain thereby underwent open repair with removal of synthetic mesh and implant of bard soft mesh (device 2).Per operative notes, ¿multiple midline fascial defects were identified.Several adhesions of small bowel and old synthetic mesh.The synthetic mesh with heavy scar was excised and fascial defect was closed with sutures.A bard soft mesh (device 2) was placed onto the peritoneum and secured with sutures.¿ on (b)(6) 2019 ¿ patient was diagnosed with recurrent incisional hernia and pain thereby underwent open repair with partial removal of previously placed mesh (device 2) and implant of ventralex st (device 3).Per operative notes, ¿hernia above the previous repair was noted and sac was excised.The mesh (device 2) was slightly dissected, and fascial defect was closed with sutures and ventralex st (device 3) was placed.¿.
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-2018) 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 perfix plug (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: 22911102
• Report Number: 1213643-2025-00797
• Device Sequence Number: 9221275
• Product Code: FTL
• UDI-Device Identifier: 00801741030932
• UDI-Public: (01)00801741030932(17)230528(10)HUCT0454
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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: 05/28/2023
• Device Catalogue Number: 0117016
• Device Lot Number: HUCT0454
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2018
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 103 KG