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	Scar Tissue (2060); Hernia (2240)
Date of Event	01/09/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2013: patient was diagnosed with bilateral inguinal scrotal hernia and right sided ventral hernia thereby underwent open repair with implant of two bard flat meshes (device 1 and 2).Per operative notes, ¿in the left side, a large indirect sac with omental incarceration down in scrotum was noted.The sac was dissected and ligated, the sac was closed primarily, and bard flat mesh (device 1) was placed to the inguinal ligament and secured with sutures.In the right side, a hernia in the direct floor originating from prior prostatectomy incision and another hernia passing down into scrotum with large scrotal sac was noted.The entire direct floor had to be patched all the way to the midline.The defect densely adherent in scrotum and sac was amputated and reduced.The fascia was closed and secured with sutures.Another bard flat mesh (device 2) was placed over the direct hernia defect and secured the mesh (device 2) with sutures.¿ (b)(6) 2015 - patient was diagnosed with recurrent left inguinal hernia and recurrent ventral incisional hernia thereby underwent open repair with implant of two perfix plug (device 3 and 4).Per operative notes, ¿a direct floor recurrence at the pubic tubercle with piece of mesh (device 1) and hernia recurred from prior prostatectomy was noted.The scar tissues from prior surgeries were retracted.Two perfix plugs (device 3 and 4) were placed over the defects and secured them circumferentially.¿ (b)(6) 2017 - patient was diagnosed with recurrent left inguinal hernia thereby underwent laparoscopic repair with 3dmax mesh (device 5) and removal of mesh (device 3).Per operative notes, ¿in the left inguinal area, the large hernia was dissected free and reduced.A piece of perfix plug (device 3) attached to the left side was floating in and out of this.The mesh (device 3) was removed.A 3dmax mesh (device 5) was placed within the abdomen covering direct, indirect and femoral spaces.The fascia was closed and secured with 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 mdr represents the bard flat mesh (device 2).Additional supplemental emdrs were submitted to represent the bard flat mesh (device 1) and perfix plug (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 ; 8005566756
• MDR Report Key: 24545350
• Report Number: 1213643-2026-00301
• Device Sequence Number: 18512941
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530(17)170928(10)HUWI0682
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 03/04/2026

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: 09/28/2017
• Device Catalogue Number: 0112680
• Device Lot Number: HUWI0682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/09/2026
• 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 Age: 84 YR
• Patient Sex: Male
• Patient Weight: 79 KG