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 Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6)2015 - patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of perfix plug (device 1), bard flat mesh (device 2).Per op notes, "a direct inguinal hernia was identified and dissected.The direct component was reduced and perfix plug (device 1) was secured to the area of deep inguinal ring, the patch was secured to pubic tubercle." on (b)(6)2018 - patient was diagnosed with chronic left groin pain, thereby underwent laparoscopic repair with implant of 3dmax mesh (device 3).Per op notes, "a moderate hiatal hernia was identified.There was no recurrent left inguinal hernia.The previously placed plug (device 1) was found compressing on spermatic structures.A 3dmax mesh (device 3) was placed in the left groin area and was sutured.The old scar in the left groin was noted.Extensive adhesions between the mesh and the external oblique, conjoined tendon, spermatic vessels, vas deferens were noted.The perfix plug (device 1) and bard flat mesh (device 2) was excised.".
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-apr-2012) 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 perfix plug (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 ; +1(800)556-6756
• MDR Report Key: 50797644
• Report Number: 1213643-2026-01203
• Device Sequence Number: 10571080
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530(17)170428(10)HUWD0434
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: Preamendment
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 04/28/2017
• Device Catalogue Number: 0112680
• Device Lot Number: HUWD0434
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2012
• 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