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

Catalog Number	0112640
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	10/30/2013
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-nov-2009) is considered to be a best estimate.This mdr represents the bard flat mesh (device 2).An additional supplemental emdr was submitted to represent the bard flat mesh (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: on (b)(6) 2011 ¿ patient was diagnosed with recurrent right inguinal femoral hernia thereby underwent open repair with implant of two bard flat meshes (device 1 and 2).Per operative notes, ¿in the right femoral region, a dense scar tissue and hernia was noted.There was a dense adherence of the unknown mesh to the external oblique fascia as well as spermatic cord.The bard flat mesh (device 1) was placed joining the transverse arch above and joining the unknown mesh inferiorly to cooper¿s ligament with sutures.The wide mouth of hernia sac on the basis of the rheumatoid arthritis within the pelvis was noted and another bard flat mesh (device 2) was placed into the defect medial to the femoral vein and secured with sutures.The fascia was closed and secured with sutures.(note: the mesh noted during this procedure is unknown) on (b)(6) 2013 ¿ patient was diagnosed with recurrent bilateral inguinal hernia thereby underwent laparoscopic bilateral inguinal hernia repair with synthetic meshes.Per operative notes, ¿ a large direct indirect hernias bilaterally were noted.In the right side, flaps were created lateral to large hernia defect and hernia was reduced and piece of synthetic mesh was placed and secured medially to coopers ligament.In the left side, similarly the defect was reduced, and piece of synthetic mesh was fashioned with medial edges and secured with sutures.¿ on (b)(6) 2013 ¿ patient was diagnosed with recurrent right inguinal hernia thereby underwent laparoscopic repair with removal of prior meshes (device 1 and 2) and implant of ventralight st mesh (device 3).Per operative notes, ¿the meshes (device 1 and 2) in the right inguinal area was seen pulled away from the cooper ligament.Dense adhesions were taken down, and cooper ligament was freed down.The previous meshes (device 1 and 2) was removed and a piece of ventralight st mesh (device 3) was placed securely and secured to cooper¿s ligament.¿.

• Brand Name: BARD FLAT 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: 24456627
• Report Number: 1213643-2026-00232
• Device Sequence Number: 21324240
• Product Code: FTL
• UDI-Device Identifier: 00801741016493
• UDI-Public: (01)00801741016493(17)150828(10)HUTK0660
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 02/19/2026

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: 08/28/2015
• Device Catalogue Number: 0112640
• Device Lot Number: HUTK0660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2009
• 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