MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Bard Flat Mesh; Surgical Mesh

Catalog Number	0112680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/17/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 - patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with the implant of two bard flat mesh (device 1 - left and 2 - right).Per op notes, "an incision over the left inguinal canal, a bard flat mesh (device 1 - left) was placed using sutures.An incision over the right inguinal canal, a bard flat mesh (device 2 - right) was placed using sutures." (b)(6) 2013 - patient was diagnosed with recurrent bilateral inguinal hernias thereby underwent laparoscopic repair with the implant of two 3dmax mesh (device 3 - left and 4 - right).Per op notes, "attention to the left first, a 3dmax mesh (device 3 - left) was placed to the cooper's ligament using tacks.Then attention to the right side, a 3dmax mesh (device 4 - right) was placed to the cooper's ligament using tacks." (b)(6) 2015 - patient was diagnosed with recurrent left inguinal hernia thereby underwent repair.Per op notes, "an incision to the left inguinal canal, the previously placed mesh (device 1 and 3) was seen which is lateral to the pubic tubercle.An unknown was placed to the pubic tubercle using prolene sutures.".
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-sep-2012) is considered to be a best estimate.This emdr represents the bard flat mesh (device 2).Additional supplemental emdrs were submitted to represent the bard flat mesh (device 1) and 3dmax mesh (device 3).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 ; +1(800)556-6756
• MDR Report Key: 50434991
• Report Number: 1213643-2026-01092
• Device Sequence Number: 9479772
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530(17)171028(10)HUWI1277
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: Preamendment
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: 10/28/2017
• Device Catalogue Number: 0112680
• Device Lot Number: HUWI1277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2012
• 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 Sex: Male
• Patient Weight: 277 LB