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

Catalog Number	0117009
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Seroma (2069); Hernia (2240)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2015 - patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of kugel hernia patches (device 1 and 2).Per op notes, ¿on the right inguinal region, the hernia defects were noted and reduced.A kugel hernia patch (device 1 - right) was placed and sutured.On the left inguinal region, a large hernia defect was noted with peritoneal fat were reduced.A kugel hernia patch (device 2 - left) was placed and sutured.¿ (b)(6) 2016 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with excision of kugel hernia patch (device 2), implant of 3dmax (device 3) and bard soft mesh (device 4).Per op notes, ¿previous left groin incision was opened.The scar tissue was excised.The prior mesh (device 2) was noted rolled up was excised and removed.The recurrent hernia is on the lateral side of old mesh.The hernia was reduced.Adhesions were lysed.A 3dmax (device 3) was placed in the preperitoneal space and sutured.A bard soft mesh (device 4) was placed as overlap and sutured.¿ (b)(6) 2018 - patient was diagnosed with abscess and infected left groin mesh thereby underwent open repair with incision and drainage of abscess and partial excision of 3dmax (device 3) and bard soft mesh (device 4).Per op notes, ¿granulated tract was excised.Abscess was drained.A infected small piece of prior meshes (device 3 and 4) were partially excised and removed.¿ (b)(6) 2018 - patient was diagnosed with recurrent left and right inguinal hernias, infected right and left groin mesh, fistula on left groin thereby underwent open repair with excision of kugel hernia patch (device 1), 3dmax (device 3), bard soft mesh (device 4) and implant of biological mesh.Per op notes, ¿midline incision was made and carried down through the preperitoneal space on the left groin.The border of 3dmax (device 3) with some tacks were palpated and excised entirely.Sinus draining tracts were noted under the mesh were excised.Fistula tract from the mesh to internal ring was excised.The overlap mesh (device 4) was also excised ad removed.Adhesions were lysed.Left cord and testicle were excised and removed.The recurrent hernia defect was noted and reduced.A biological mesh was placed on the left groin and sutured.On the right inguinal region, the mesh edges were contracted.The prior mesh (device 1) was adherent with seroma cavity were excised entirely.The recurrent hernia defect was noted and repaired 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-jul-2016) 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 kugel hernia patch (device 1) and 3dmax (device 3).An additional mdr was submitted to represent the kugel hernia patch (device 2).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: 24493753
• Report Number: 1213643-2026-00269
• Device Sequence Number: 10638165
• Product Code: FTL
• UDI-Device Identifier: 00801741030864
• UDI-Public: (01)00801741030864(17)210628(10)HUAU0152
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 02/26/2026

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: 06/28/2021
• Device Catalogue Number: 0117009
• Device Lot Number: HUAU0152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2016
• 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: 75 YR
• Patient Sex: Male