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 Abdominal Pain (1685); Inflammation (1932); Nerve Damage (1979); Pain (1994); Hernia (2240); Disability (2371); Fibrosis (3167)

Event Date 05/16/2008

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.The information provided alleges that the, "patient underwent an additional surgery to repair the hernia defect and remove it." medical records were not provided and the description does not clearly define what "remove it" is referring to (example possible mesh explant, partial explant, or removal/repair of the hernia defect itself without explant of previously placed mesh).As such at this time, we have not identified this as reported device explant.It is unclear at this time if the hernia defect repaired post implant of the mesh was a recurrence of the original hernia defect or a new hernia defect, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.The information provided by bard 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 bard.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2006 - the patient underwent surgery for repair of a right inguinal hernia, a bard/davol 3dmax mesh was implanted to repair the hernia defect.On (b)(6) 2008 - the patient underwent an additional surgery to repair the hernia defect and remove it.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.

Manufacturer Narrative

Addendum to the previous report.This supplemental emdr is being sent to report the correct date of expiration for the 3dmax mesh.A manufacturing review was performed which found that the device provided was manufactured to specification.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, this report will be updated.

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.The information provided alleges that the, "patient underwent an additional surgery to repair the hernia defect and remove it." medical records were not provided and the description does not clearly define what "remove it" is referring to (example possible mesh explant, partial explant, or removal/repair of the hernia defect itself without explant of previously placed mesh).As such at this time, we have not identified this as reported device explant.It is unclear at this time if the hernia defect repaired post implant of the mesh was a recurrence of the original hernia defect or a new hernia defect, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum#1: this supplemental emdr is being sent to report the correct date of expiration for the 3dmax mesh.A manufacturing review was performed which found that the device provided was manufactured to specification.Addendum#2: h11: this supplemental mdr is submitted to document additional information provided and to correct manufacturing date.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical record review, about 1 year 10 months post implant of 3dmax mesh, the patient had abdominal pain, fibrosis, inflammation thereby underwent repair with resection of ilioinguinal nerve.The instructions-for-use supplied with the device list inflammation as a possible complication and the attorney alleges nerve damage, per the warnings section statement, "careful attention is required if fixating the mesh in the presence of nerves or vessels." 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 Description

The following was reported to davol by the patient's attorney: (b)(6) 2006 - the patient underwent surgery for repair of a right inguinal hernia, a bard/davol 3dmax mesh was implanted to repair the hernia defect.(b)(6) 2008 - the patient underwent an additional surgery to repair the hernia defect and remove it.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.Addendum per additional information provided: (b)(6) 2006 - patient was diagnosed with right inguinal hernia and underwent laparoscopic repair with implant of 3dmax mesh.Per operative report, "there was a flaccid hernia sac attached to the spermatic cord.It was dissected free off the cord and dropped into the preperitoneal floor space.The defect appeared to be an indirect hernia.A medium sized bard 3dmax mesh was then rolled and placed into the preperitoneal space and anchored¿.(b)(6) 2008 - patient had persistent right groin pain and underwent repair with resection of right ilioinguinal nerve.Per the operative report details, "there was inflammation from the underlying mesh onto the cremasteric muscle, on which the ilioinguinal nerve laid.A simple resection of the portion of nerve where the fibrosis was in its closest proximity may lead to relief of pain.The mesh laid deep in the inguinal canal and was well encapsulated, appeared to be intact.Therefore, a small section of the ilioinguinal nerve was resected between clamps¿.Attorney alleges that the patient experienced infection, nerve damage, sexual dysfunction, permanent tingling/burning sensation in groin and emotional injuries.

• 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: 7153875
• MDR Text Key: 96014143
• Report Number: 1213643-2017-01136
• 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,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2009
• Device Model Number: 0115320
• Device Catalogue Number: 0115320
• Device Lot Number: 43CQD475
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2006
• 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: 26 YR
• Patient Sex: Male