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

Model Number 0115320

Device Problems Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Hernia (2240); Disability (2371)

Event Date 12/30/2009

Event Type  Injury  

Manufacturer Narrative

To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.If additional information is obtained, a supplemental mdr will be submitted.Not returned.

Event Description

(b)(4).It is alleged by the patients attorney that on (b)(6) 2007, the patient underwent surgery for repair of an inguinal hernia.As reported, a bard/davol 3dmax, (b)(4), lot number 43dqd515 was implanted to repair the hernia defect.It is alleged that on (b)(6) 2009, the patient underwent an additional surgery for recurrence repair.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective 3dmax.

Event Description

Per legal complaint no.: (b)(4) it is alleged by the patients attorney that on (b)(6) 2007, the patient underwent surgery for repair of an inguinal hernia.As reported, a bard/davol 3dmax, reference number (b)(4), lot number 43dqd515 was implanted to repair the hernia defect.It is alleged that on (b)(6) 2009, the patient underwent an additional surgery for recurrence repair.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective 3dmax.Addendum per additional information provided: on (b)(6) 2007 - patient was diagnosed with symptomatic right inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax mesh.Per operative notes, ¿the lipoma of the cord was identified and dissected until it was completely removed.Then the sac was found lateral to the epigastric vessels and dissected.The mesh was placed and it was secured to the pubic bone and to the cooper ligament.¿ on (b)(6) 2009 - patient was diagnosed with recurrent right indirect inguinal hernia thereby underwent open repair.Per operative notes, ¿incision was made in the direction of the right inguinal ligament.The hernia in the anteromedial aspect of the cord that was found to be indirect.Some preperitoneal fat, hernia sac were found and sutured.At this point, the mesh was then placed to reinforce the posterior wall of the canal and the internal inguinal ring and sutured.¿ (note: no mention/visualization of 3dmax mesh during the procedure and an unspecified mesh was implanted) attorney alleged that the patient had pain, hernia recurrence and emotional injuries.

Manufacturer Narrative

To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.If additional information is obtained, a supplemental mdr will be submitted.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the expiry date, manufacturing date and pma/510(k).Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 2 years implant of 3dmax mesh, patient was diagnosed with hernia recurrence thereby underwent repair.A review of the manufacturing records was performed and found that the lot was manufactured to specification.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.

• Brand Name: 3DMAX
• Type of Device: 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: 7140377
• MDR Text Key: 95589682
• Report Number: 1213643-2017-01095
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2011
• Device Model Number: 0115320
• Device Catalogue Number: 0115320
• Device Lot Number: 43DQD515
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male