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	Nerve Damage (1979); Pain (1994)
Date of Event	05/20/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information received, (b)(6) 2014 - patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of bard flat mesh (device 1 and 2).Per op notes, ¿the hernia sacs were identified bilaterally and mobilized.The sacs were transected.A bard flat mesh (device 1) on right side and another bard flat mesh (device 2) on left side were placed and secured using sutures.¿ (b)(6) 2014 - patient was diagnosed with post operative wound infection and bilateral inguinal pain thereby underwent open repair with excision of bard flat mesh (device 1) and implant of biological mesh.Per op notes, ¿on the right inguinal region, draining sites were noted and excised.The old mesh (device 1) was slightly displaced around the testicular cord creating tight adhesions around the cord and it was tediously mobilized and adhesions were taken down.The old mesh (device 1) was excised entirely.The ilioinguinal and genitofemoral nerves were identified and some sections were transected.A biological mesh was placed and tacked.On the left inguinal region, the mesh (device 2) was not visible.The ilioinguinal and genitofemoral nerves between internal and external oblique were identified and some sections were transected.¿ (b)(6) 2014 - patient was diagnosed with abscess and mrsa infection on right groin thereby underwent open repair excision of biological mesh.Per op notes, ¿the wound was draining excised.The biological mesh was excised.The abscess cavity was identified and irrigated.The wound vac was placed.¿ (b)(6) 2015 - patient was diagnosed with recurrent right inguinal hernia thereby underwent robotic assisted repair with implant of 3dmax light (device 3).Per op notes, ¿an indirect hernia sac was identified, dissected free and reduced.A 3dmax light (device 3) was placed and sutured to cooper ligament.¿.
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-nov-2013) is considered to be a best estimate.This mdr represents the bard flat mesh (device 2).An additional emdrs were submitted to represent the bard flat mesh (device 1) and 3dmax light (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: 24690104
• Report Number: 1213643-2026-00367
• Device Sequence Number: 10042458
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530(17)181128(10)HUXK0374
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/19/2026

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: 11/28/2018
• Device Catalogue Number: 0112680
• Device Lot Number: HUXK0374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2013
• 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: Disability; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male