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

Catalog Number	0112730
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	02/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per plaintiff profile form (b)(4): attorney alleges that the patient had pain and hernia recurrence.Per medical records: on (b)(6) 2015 - patient was diagnosed with recurrent right groin incisional hernia thereby underwent open repair with the implant of perfix plug (device #1) and dart mesh (device #2).Per operative notes, ¿the incisional hernia was identified and a small dart plug mesh (device #2) was placed in the internal ring superior to transversalis and inferior to ilioinguinal ligament.A synthetic mesh was trimmed and placed under external oblique fascia.An obvious fascial defect with protruding peritoneal fat was identified, repaired using trimmed perfix plug (device #1).Then, the synthetic mesh was placed over this and secured to the pubic tubercle and ilioinguinal ligament with sutures.¿ on (b)(6) 2017 - patient was diagnosed with recurrent right inguinal hernia and right groin pain thereby underwent robotic assisted laparoscopic repair with the explant of perfix plug (device #1), dart mesh (device #2) and implant of bard soft mesh (device #3).Per operative notes, ¿encountered both groin plugs and a small hernia noted in the femoral space.The medially placed groin plug (device #1) was excised from the left peritoneal pocket.Then, plug (device #2) which placed in the indirect space was excised, found attached inferior epigastric vessels on the right underlying plug.Recurrence also noted in the indirect space, a piece of bard soft mesh (device #3) placed covering all three hernia defects in the right pelvic floor and sutured.¿ attorney alleges that the patient had pain and hernia recurrence.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 1 year 1 month post implant of dart mesh, patient was diagnosed with adhesions, pain and hernia recurrence thereby underwent repair with removal of the mesh.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the mesh ¿dart (device #2).An additional supplemental emdr was submitted to represent the perfix plug (device #1).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 ¿ DART
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 19679012
• Report Number: 1213643-2024-093361
• Device Sequence Number: 6917663
• Product Code: FTL
• UDI-Device Identifier: 00801741016578
• UDI-Public: (01)00801741016578
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2024

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: 06/28/2020
• Device Catalogue Number: 0112730
• Device Lot Number: HUZF0116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2015
• 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: 41 YR
• Patient Sex: Female