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

Catalog Number	0110151
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240)
Date of Event	05/06/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 - patient was diagnosed with complex recurrent left inguinal hernia thereby underwent open repair with the implant of bard dulex mesh.Per operative notes, "the hernia sac was dissected free from the femoral canal into the groin area, the previously placed unknown mesh was dislodged from the hernia sac.The previous unknown mesh was excised from it's inflammatory mass in the inguinal canal.The hernia defect was closed and reduced.A bard dulex mesh (device #1) was placed medial to the pubic tubercle along the inguinal ligament and sutured." (b)(6) 2014 - patient was diagnosed with bilateral symptomatic recurrent inguinal hernia thereby underwent robotic assisted transabdominal laparoscopic preperitoneal bilateral inguinal hernia repair with implant of 3dmax light meshes (device #2 & #3).Per operative notes, "the bilateral inguinal hernia was noted, the preperitoneal mesh (device #1) was seen.The mesh was adherent to the peritoneum.The large hernia sac was reduced on the left side.The same process was done on right side.A 3dmax light mesh (device #2) sutured to cooper ligament in interrupted fashion on left side, similar repair was done of right side using 3dmax light mesh (device #3) attached to the coopers ligament." (b)(6) 2015 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the explant of mesh and implant of perfix plug (device #4).Per operative notes, "scar tissue was noted, upon entering external oblique fascia the mesh was removed with prolene sutures.A large defect in the floor was seen and the mesh was completely off the floor.A perfix plug was anchored." (b)(6) 2017 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with explant of mesh (device #2) and implant of ventralex st (device #5) and bard soft mesh (device #6).Per operative notes, "there was matted scar tissue meshoma noted, upon incising the fascial defect was identified.The defect was more lateral than spermatic cord.A ventralex st (device #5) was placed through the defect and sutured.A bard flat mesh (device #6) was placed over to reinforce the repair and sutured.The scarred mesh (device #2) were excised." attorney alleged that the patient had adhesions, mesh migration, mesh shrinkage, pain and hernia recurrence.It was also alleged that the patient had injuries resulting from meshoma and excision of previous mesh, permanent and severe scarring and disfigurement.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 2 years, 7 months post implant of dulex mesh, patient was diagnosed with hernia recurrence, adhesion, pain and scar tissue thereby underwent removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence and adhesion as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the dulex mesh (device #1).An additional supplemental emdr was submitted to represent the perfix plug (device #4) and an additional emdr was submitted to represent the 3dmax light mesh (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: MESH ¿ DULEX
• 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 ; 4018258495
• MDR Report Key: 21523608
• Report Number: 1213643-2025-090119
• Device Sequence Number: 8339423
• Product Code: FTL
• UDI-Device Identifier: 00801741011795
• UDI-Public: (01)00801741011795(17)160928(10)BRVK0022
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K003917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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: 09/28/2016
• Device Catalogue Number: 0110151
• Device Lot Number: BRVK0022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 110 KG