MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD MESH PRE-SHAPED W/ KEYHOLE; SURGICAL MESH

Model Number 0112710

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

Patient Problems Abdominal Pain (1685); Pain (1994); Hernia (2240); Disability (2371)

Event Date 01/08/2016

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.Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2009 - the patient underwent surgery for repair of a inguinal hernia.A bard/davol "marlex," reference number (b)(4) and lot number hutd1198 was implanted to repair the hernia defect.On (b)(6) 2016 - the patient underwent an additional surgery to repair the hernia defect and remove it.The patient has suffered and will continue to suffer pain and was injured severely and permanently.

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: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 6 years post implant of bard mesh pre-shaped with keyhole, patient was diagnosed with hernia recurrence, abdominal pain thereby underwent additional surgery.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.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2009 - the patient underwent surgery for repair of a inguinal hernia.A bard/davol "marlex," reference number 0112710 and lot number hutd1198 was implanted to repair the hernia defect.(b)(6) 2016 - the patient underwent an additional surgery to repair the hernia defect and remove it.The patient has suffered and will continue to suffer pain and was injured severely and permanently.Addendum per additional information provided: (b)(6) 2009 - patient was diagnosed with recurrent direct right inguinal hernia thereby underwent open repair with the implant of bard mesh pre-shaped with keyhole.Per operative notes, ¿patient was noted to have a large direct hernia in the floor of the canal.Once the direct hernia was reduced, a bard mesh pre-shaped with keyhole was placed over the floor of the inguinal canal and sutured.¿ (b)(6) 2016 - patient was diagnosed with right groin pain, bilateral inguinal hernia without obstruction thereby underwent laparoscopic repair.Per operative notes, ¿on left side, dissected the cord structures away from the pelvic wall.A polypropylene mesh was placed into the abdomen covering both indirect and direct spaces of the hernia on both sides.On right side, larger hernia was found.The indirect hernia was larger on this side and after dissection, able to pull the hernia sac away from the abdominal wall, retracted back towards the head of the patient.A polypropylene mesh was placed covering both direct, indirect, and femoral site.¿ (note: there is no mention/visualization of bard mesh pre-shaped with keyhole in operative notes) 10-jan-2016 - patient was diagnosed with bladder injury thereby underwent bladder repair.Per operative notes, ¿identified a piece of mesh which was still intact and left the mesh intact due to the proximity of the findings.¿ attorney alleges that the patient had pain, hernia recurrence and emotional injuries.

• Brand Name: BARD MESH PRE-SHAPED W/ KEYHOLE
• 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: 7153026
• MDR Text Key: 96005212
• Report Number: 1213643-2017-01133
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016554
• UDI-Public: (01)00801741016554
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2014
• Device Model Number: 0112710
• Device Catalogue Number: 0112710
• Device Lot Number: HUTD1198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2009
• 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: 38 YR
• Patient Sex: Male
• Patient Weight: 77 KG