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

Catalog Number	0115310
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hernia (2240)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 12 years 7 months post implant of 3dmax mesh, patient was diagnosed with hernia recurrence thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.This emdr represents the 3dmax (device #2).An additional supplemental emdr was submitted to represent the 3dmax (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 additional information provided: on (b)(6) 2006 - patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with the implant of two 3dmax mesh (device#1 & device #2).Per operative notes, ¿the left indirect hernia was identified and dissected free from the cord structures, and it was completely removed.A similar procedure was performed in the right preperitoneal space.And the indirect hernia sac was identified and easily dissected.A 3dmax mesh (device#1) was placed in the right side anchored to the pubic tubercle using tacks.A left sided 3dmax mesh (device#2) was placed in the similar fashion and tacked in a similar fashion.¿ on (b)(6) 2010 - patient was diagnosed with chronic right groin pain thereby underwent laparoscopic resection of right ilioinguinal nerve.(both prior laparoscopic hernia repairs were well visualized and well intact, without evidence of recurrent herniation) on (b)(6) 2019 - patient was diagnosed with bilateral inguinal hernia thereby underwent robotic-assisted diagnostic laparoscopy with explant of both 3dmax mesh (device #1 and device #2).Per operative notes, ¿there was some bold 3dmax mesh in the right abdominal region and what seemed to be a folded over mesh.It was excised (device #1).Then in the left abdominal region, there was a bold up mesh and a very subtle and small direct hernia.Then the 3dmax mesh was removed (device #2).¿ attorney alleged that the patient had adhesions, nerve damage, pain, hernia recurrence and emotional injuries.It is also alleged that the patient underwent resection of right ilioinguinal nerve and mesh excision.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 12 years 7 months post implant of 3dmax mesh, patient was diagnosed with hernia recurrence thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence as possible complication.Addendum: h11: this supplemental emdr is submitted to update event description, imdrf codes and to correct the product catalog no.And pma/510(k).Updated fields: d4 (udi no.).Corrected fields: d4 (product catalog no.), g4 (pma/510(k).This supplemental emdr represents the 3dmax (device #2).An additional supplemental emdr was submitted to represent the 3dmax (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.
Event or Problem Description
Per information provided: on (b)(6) 2006: patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with the implant of two 3dmax mesh (device#1 & device #2).Per operative notes, ¿the left indirect hernia was identified and dissected free from the cord structures, and it was completely removed.A similar procedure was performed in the right preperitoneal space.The indirect hernia sac was identified and easily dissected.A 3dmax mesh (device#1) was placed in the right side anchored to the pubic tubercle using tacks.A left sided 3dmax mesh (device#2) was placed in the similar fashion and tacked in a similar fashion.¿ on (b)(6) 2010: patient was diagnosed with chronic right groin pain thereby underwent laparoscopic resection of right ilioinguinal nerve.(both prior laparoscopic hernia repairs were well visualized and well intact, without evidence of recurrent herniation).On (b)(6) 2019: patient was diagnosed with bilateral inguinal hernia, inguinodynia thereby underwent robotic-assisted diagnostic laparoscopy with explant of two balled 3dmax mesh (device #1 and device #2).Per operative notes, ¿there was some bold 3dmax mesh in the right abdominal region and what seemed to be a folded over mesh.It was excised (device #1).Then in the left abdominal region, there was a bold up mesh and a very subtle and small direct hernia.Then, the 3dmax mesh was removed (device #2).¿ attorney alleged that the patient had adhesions, nerve damage, pain, hernia recurrence and emotional injuries.It is also alleged that the patient underwent resection of right ilioinguinal nerve and mesh excision.

• 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: 20671921
• Report Number: 1213643-2024-094813
• Device Sequence Number: 8207953
• Product Code: FTL
• UDI-Device Identifier: 00801741030727
• UDI-Public: (01)00801741030727(10)43LPD321
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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 Catalogue Number: 0115310
• Device Lot Number: 43LPD321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/26/2024
• 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: 65 YR
• Patient Sex: Male