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

Catalog Number	0112640
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/06/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2013 - patient was diagnosed with recurrent bilateral inguinal hernias thereby underwent open repair with the implant of two bard flat meshes (device 1 and 2).Per op notes, "a right groin incision was made, the previous synthetic mesh had pulled away from the fascia.A bard flat mesh (device 1) was placed using sutures.An incision was made through the left groin scar; the previous synthetic mesh had pulled away from the fascia.A bard flat mesh (device 2) was placed using sutures." (b)(6) 2015 - patient was diagnosed with recurrent bilateral inguinal hernias thereby underwent laparoscopic repair with the implant of two 3dmax meshes (device 3 and 4).Per op notes, "the right inguinal hernia was seen, the mesh (device 1) was found.A 3dmax mesh (device 3) was placed to the right preperitoneal space using tacks.Attention to the left side, there was mesh (device 2) freeing of the peritoneum and direct recurrence was identified.A left sided 3dmax mesh (device 4) was placed to the left preperitoneal space using tacks.".
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-feb-2013) is considered to be a best estimate.This emdr 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.

• 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: 23786841
• Report Number: 1213643-2025-01188
• Device Sequence Number: 20226476
• Product Code: FTL
• UDI-Device Identifier: 00801741016493
• UDI-Public: (01)00801741016493(17)180228(10)HUXB0076
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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: 02/28/2018
• Device Catalogue Number: 0112640
• Device Lot Number: HUXB0076
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2013
• 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; Disability
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 79 KG