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

Catalog Number 0113710

Device Problems Defective Device (2588); No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Pain (1994); Hernia (2240); Disability (2371); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2015

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient.The patient's attorney did not allege a specific device failure and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction section of the instructions-for-use as a possible complication.Should additional information be obtained, a supplemental emdr will be submitted.This emdr represents the bard/davol "marlex" mesh and additional emdr was submitted to document information related to the bard/davol perfix plug.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.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2015 - the patient underwent surgery to repair a right inguinal hernia.As reported, a bard/davol "marlex" mesh and a bard/davol perfix plug were implanted to repair the hernia defect.On (b)(6) 2015 - the patient underwent an additional surgery to repair a recurrent right inguinal hernia.The attorney for the patient alleges that the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the defective mesh products.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2015 - the patient underwent surgery to repair a right inguinal hernia.As reported, a bard/davol "marlex" mesh and a bard/davol perfix plug were implanted to repair the hernia defect.(b)(6) 2015 - the patient underwent an additional surgery to repair a recurrent right inguinal hernia.The attorney for the patient alleges that the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the defective mesh products.Addendum per additional information provided: (b)(6) 2015 - patient was diagnosed with right inguinal hernia thereby underwent laparoscopic repair with the implant of bard soft mesh (device #1) on 04-jun-2015.Per operative notes, ¿the peritoneal contents off the cord structures at the level of the umbilicus were dissected.A piece of bard soft mesh (device #1) was placed centered on the internal ring, tucked down under the peritoneum inferiorly.¿ (b)(6) 2015 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with the implant of bard mesh pre-shaped w/ keyhole (device #2) and perfix plug (device #3).Per operative notes, ¿an indirect hernia sac was identified.A extra-large perfix plug (device #3) was fixed to the undersurface of the deformed abdominal wall and the "shutter" of the internal oblique.A bard preshaped w/ keyhole patch (device #2) was placed and then fixed to the fascia of the inguinal floor, at the pubis, along the shelving edge.¿ (note, there was no mention/visualization of device #1 during the repair) attorney alleges that the patient had adhesions, bowel obstruction, pain, hernia recurrence and emotional injuries.

Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient.The patient's attorney did not allege a specific device failure and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Recurrence is a known inherent risk of hernia repair surgery and is listed in the advserse reaction section of the instructions-for-use as a possible complication.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct date of event, date of implant and brand name.Upon review of medical records, it was confirmed there was no adverse event or medical/surgical intervention associated to the bard mesh pre-shaped w/ keyhole implanted to treat the patient's right inguinal hernia.Updated fields: a2, b4, b5, b7, e3, g1, g3, g6, h2, h6, h10, h11 corrected field: b3 (date of event), d1 (brand name) and d6 (date of implant) this supplemental emdr represents the bard mesh pre-shaped w/ keyhole (device #2).An additional supplemental emdr was submitted to represent the perfix plug (device #3) and an emdr was submitted to represent the soft mesh(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.

• 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: 7139364
• MDR Text Key: 95533833
• Report Number: 1213643-2017-01086
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030703
• UDI-Public: (01)00801741030703
• 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: 12/19/2023

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: 09/28/2019
• Device Catalogue Number: 0113710
• Device Lot Number: HUYI1990
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• 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: 79 YR
• Patient Sex: Male