MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD SOFT MESH PRE-SHAPED W/ KEYHOLE; SURGICAL MESH

Catalog Number	0117013
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	07/30/2018
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-2015) is considered to be a best estimate.This emdr represents the bard soft pre-shaped mesh (device 2).An additional supplemental emdr was submitted to represent the ventrio 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 information provided: (b)(6) 2015 - patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of ventrio st mesh (device 1).Per operative notes, ¿an incision was made superior to the inguinal ligament over the external ring and carried down to the fascia of the external oblique.The left inguinal hernia sac was dissected out.A ventrio st mesh (device 1) was placed into the left inguinal region and secure it with sutures.¿ (b)(6) 2016 - patient was diagnosed with recurrent left inguinal hernia, adhesion thereby underwent open repair with implant of bard soft pre-shaped mesh (device 2).Per operative notes, ¿an incision was made and carried down to the external oblique.The hernia sac was dissected out.All adhesions were taken down.Lysis of adhesions were performed.A bard soft pre-shaped mesh (device 2) was placed and anchored at the pubic tubercle with sutured.¿ (b)(6) 2018 ¿ patient was diagnosed with recurrent left inguinal hernia, adhesion, thereby underwent laparoscopic repair with implant of 3dmax mesh (device 3) and lysis of adhesion.Per operative notes, ¿an incision was made infraumbilical and carried down to the level of the fascia.The hernia sac was dissected out.All adhesions were taken down from previously placed mesh.Lysis of adhesions were taken down.A large 3dmax mesh (device 3) was placed into the abdominal wall and secure it with sutures.¿.

• Brand Name: BARD SOFT MESH PRE-SHAPED W/ KEYHOLE
• 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: 24311493
• Report Number: 1213643-2026-00102
• Device Sequence Number: 5650079
• Product Code: FTL
• UDI-Device Identifier: 00801741030901
• UDI-Public: (01)00801741030901(17)200928(10)HUZJ0314
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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: 09/28/2020
• Device Catalogue Number: 0117013
• Device Lot Number: HUZJ0314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2015
• 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: Male
• Patient Weight: 97 KG