MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX; SURGICAL MESH

Catalog Number	0115310
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	03/24/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about a month post implant of 3dmax mesh, patient was diagnosed with hernia recurrence, adhesion and scar tissue thereby underwent repair with mesh removal.The instructions-for-use supplied with the device list hernia recurrence, adhesion as a possible complications.Review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-sep-2013) is considered to be a best estimate.This emdr represents bard/davol 3dmax mesh (device #2).Additional supplemental emdr's were submitted to represent the bard/davol perfix plug (device #4) and bard flat mesh (device #3) and also an additional emdr was submitted to represent the bard/davol modified kugel patch (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.H3 other text: not returned.
Event or Problem Description
Per information provided by patient¿s attorney: (b)(6) 2013 - patient was diagnosed with symptomatic left incarcerated indirect inguinal hernia thereby underwent open repair with the implant of modified kugel patch (device #1).Per operative notes, ¿indirect sac was separated from cord.Hernia sac contain incarcerated omentum was reduced into the peritoneal cavity.The modified kugel patch (device #1) was placed extraperitoneally covering direct, indirect and femoral spaces, and attached to the periosteum of cooper ligament with a single suture.¿ (b)(6) 2014 - patient was diagnosed with symptomatic recurrent left inguinal hernia thereby underwent laparoscopic repair with the implant of 3dmax mesh (device #2).Per operative notes, ¿adhesions are taken down.Hernia filled with fat was removed.The previously placed mesh (device #1) had migrated inferiorly.The 3dmax mesh (device #2) for a left inguinal hernia was placed into the extraperitoneal space over pubic tubercle and tacked.¿ (b)(6) 2014 - patient was diagnosed with symptomatic recurrent incarcerated left indirect inguinal hernia thereby underwent open repair with the implant of bard flat mesh (device #3).Per operative notes, ¿a large indirect inguinal hernia within the spermatic cord was separated and excised completely.The hernia defect was repaired using bard flat mesh (device #3) and attached to conjoined tendon and shelving edge of poupart ligament and secured with suture.¿ (note: there is no mention/visualization of device #1, device #2 in this procedure.) (b)(6) 2014 - patient was diagnosed with nonreducible recurrent left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #4).Per operative notes, ¿incarcerated hernia sac was removed.In previous repair that there had been separation of the mesh (device #3) from its lateral attachments was reattached to the shelving portion of the inguinal ligament to reconstruct the floor.The perfix plug (device #4) had been placed in the patulous recurrent internal inguinal ring.¿ (b)(6) 2016, patient was diagnosed with multiple recurrent left inguinal hernia thereby underwent removal of meshes (device #1, #2, #3, #4) and implant of bard soft mesh (device #5).Per operative notes, ¿multiply recurrent left-sided inguinal hernia was noted.There are several pieces of mesh in the abdominal wall on the left-hand side, there appears to be a piece of onlay mesh within which there is a recurrence of an indirect hernia containing colon.Medial to recurrence, a polypropylene plug and then medial to the plug is a laparoscopically placed piece of polypropylene mesh was identified.The meshes (device #1, #2, #3, #4) adhesed to the floor was dissected.There were several very small defects and scar tissue due to multiple pieces of mesh.Aa subtotal excision was performed to remove all the meshes (device #1, #2, #3, #4).A bard soft mesh (device #5) was placed into the pelvis, secured to cooper's ligament, to the right and to the left of the midline and splayed out laterally over the cord structures.¿ attorney alleges that the patient had adhesions, mesh shrinkage, mesh migration, pain, hernia recurrence and seroma.It was also alleged that the patient had hernia attached to spermatic cord, mesh separated from lateral attachments.

• Brand Name: 3DMAX
• 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: 21533453
• Report Number: 1213643-2025-090123
• Device Sequence Number: 18053097
• Product Code: FTL
• UDI-Device Identifier: 00801741030727
• UDI-Public: (01)00801741030727(17)180928(10)HUXI0603
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• 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: 09/28/2018
• Device Catalogue Number: 0115310
• Device Lot Number: HUXI0603
• 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: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2013
• 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: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 115 KG