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	02/12/2016
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.This mdr represents the bard flat mesh (device 2).An additional supplemental emdr was submitted to represent the bard flat mesh (device 1).Note, the manufacturing date (15-aug-2014) is considered to be a best estimate.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) 2013 - patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of bard flat mesh (device 1).Per operative notes, ¿an incision was made into the left inguinal region.The hernia sac was dissected out.A bard flat mesh (device 1) was placed into the defect and secure it with sutures.¿ on (b)(6) 2014 ¿ patient was diagnosed with recurrent left inguinal hernia; scar tissue hereby underwent laparoscopic repair with implant of bard flat mesh (device 2) and explant of bard flat mesh (device 1).Per operative notes, ¿an incision was made through old incisional site.The hernia sac was dissected out.The prior (device 1) was identified which was removed entirely.A bard flat mesh (device 2) was placed into the left inguinal floor and secure it with sutures.¿ on (b)(6) 2016 - patient was diagnosed with bilateral inguinal hernias thereby underwent laparoscopic repair with implant of two 3dmax mesh (device 3 ¿ left and device 4 ¿ right).Per operative notes, ¿an infraumbilical incision was made in the prior umbilical hernia scar.Both hernia sacs were dissected out.Two 3dmax mesh (device 3 ¿ left and device 4 ¿ right) was placed into the right and left inguinal floor and secure it with sutures.¿.

• 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: 25163529
• Report Number: 1213643-2026-00631
• Device Sequence Number: 18285037
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530(17)190728(10)HUYH0132
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: 07/28/2019
• Device Catalogue Number: 0112680
• Device Lot Number: HUYH0132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2014
• 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