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

Catalog Number	0117008
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/11/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2004 ¿ patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with the implant of 3dmax meshes (right - device 1, left- device 2).Per op notes, ¿inguinal hernias were noted.A medium 3dmax mesh (device 1) was placed accordingly on the right- side and tacked to the pubic tubercle medially along coopers ligament and then up on the rectus fascia anteriorly.In likewise fashion, the left inguinal hernia was repaired with left sided 3dmax mesh (device 2).¿ on (b)(6) 2008 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of perfix plug (device 3).Per op notes, ¿direct hernia defect was palpable inferior to the inguinal floor just superior to the inguinal ligament.A small perfix plug (device 3) was placed, and patch was placed to reinforce the floor using sutures.¿ on (b)(6) 2014 ¿ patient was diagnosed with severe left groin pain thereby underwent open repair with the removal of meshes (device 2, 3) and implant of bard soft mesh (device 4).Per op notes, ¿the underlying previously existing mesh (device 2, 3) had torn completely away from deep space and completely balled up near the pubic tubercle was excised.A piece of bard soft mesh (device 4) was placed and secured to pubic tubercle along the shelving edge of inguinal ligament using sutures.¿ on (b)(6) 2014 ¿ patient was diagnosed with recurrent left inguinal hernia thereby underwent laparoscopic repair with the partial removal of mesh (device 4) and implant of 3dmax mesh (device 5).Per op notes, ¿abdominal wall revealed peritonealised bilateral piece of mesh.The mesh on the left side appeared more superior.The previously placed piece of mesh (device 4) was dissected from the anterior abdominal wall.A piece of left sided 3dmax mesh (device 5) was placed into left preperitoneal space and fixed medially to cooper ligament and previous mesh 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-2014) is considered to be a best estimate.This mdr represents the bard soft mesh (device 4).Additional supplemental emdr's were submitted to represent the 3dmax mesh (device 2) 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 SOFT 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: 24455559
• Report Number: 1213643-2026-00227
• Device Sequence Number: 9620803
• Product Code: FTL
• UDI-Device Identifier: 00801741030857
• UDI-Public: (01)00801741030857(17)190228(10)HUYB0355
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: 02/28/2019
• Device Catalogue Number: 0117008
• Device Lot Number: HUYB0355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2014
• 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: 36 YR
• Patient Sex: Female
• Patient Weight: 89 KG