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

Catalog Number	0117009
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2018 ¿ patient was diagnosed with right inguinal hernia and incisional hernia thereby underwent laparoscopic repair with implant of bard soft mesh (device 1) and ventralex st mesh (device 2).Per operative notes, ¿ an incarcerated large right indirect inguinal hernia adhesed to cecum and appendix were noted.The hernia defect was reduced and adhesions were taken down.A piece of bard soft mesh (device 1) was placed over the defect and anchored to the peritoneum with sutures and staples.A small midline incisional hernia superior to the umbilicus was reduced and adhesions between omentum and peritoneum were divided.The defect was closed and medium sized ventralex st mesh (device 2) was placed over the defect and secured in place with tacks and sutures.¿ on (b)(6) 2018 ¿ patient was diagnosed with recurrent right inguinal hernia thereby underwent laparoscopic repair with implant of synthetic mesh.Per operative notes, ¿ in the right side, inguinal defect containing bowel was noted.There was a scarring from prior surgery that adhered to colon and hernia defect.The mesh (device 1) was buckled up and separated from the superior border.The hernia defect was dissected off and reduced and a piece of synthetic mesh was placed into the defect and secured with staples.¿ on (b)(6) 2018 ¿ patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with removal of old mesh (device 2) and implant of synthetic mesh.Per operative notes, ¿ a recurrent hernia in the left of the prior repair in the midline was dissected through the subcutaneous tissues.The sac was reduced free from the surrounding tissues and adhesions of omentum and bowel to prior mesh (device 2) were taken down.The mesh (device 2) was cleared, and defect was closed with sutures.The synthetic mesh was placed underneath the fascia and secured using sutures and staples.The wound was irrigated and closed.¿.
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-aug-2017) is considered to be a best estimate.This mdr represents the bard soft mesh (device 1).An additional supplemental emdr was submitted to represent the ventralex st mesh (device 2).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: 24377141
• Report Number: 1213643-2026-00163
• Device Sequence Number: 5650008
• Product Code: FTL
• UDI-Device Identifier: 00801741030864
• UDI-Public: (01)00801741030864(17)220728(10)HUBV0559
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 02/05/2026

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: 07/28/2022
• Device Catalogue Number: 0117009
• Device Lot Number: HUBV0559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2017
• 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: 69 YR
• Patient Sex: Male