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

Model Number	0112700
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hematoma (1884); Pain (1994); Hernia (2240); Disability (2371)
Date of Event	06/25/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.The information provided alleges that the, "patient underwent an additional surgery to repair the hernia defect and remove it." as 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, we have not identified this as reported device explant at this time.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.
Event or Problem Description
It is alleged by the patients attorney that on (b)(6) 2009, the patient underwent surgery for repair of an inguinal hernia.As reported, a bard/davol marlex reference number 0112700, lot number husl1076 was implanted to repair the hernia defect.It is alleged that a year later on (b)(6) 2010, the patient underwent an additional surgery to repair the hernia defect and "remove it." as alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective marlex.
Additional Manufacturer Narrative
Addendum to the previous report.This supplemental emdr is being sent to correct the brand name (d1) of the device used in the patient.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 a follow up emdr will be submitted.
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.The information provided alleges that the, "patient underwent an additional surgery to repair the hernia defect and remove it." as 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, we have not identified this as reported device explant at this time.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 correct the brand name (d1) of the device used in the patient.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 a follow up emdr will be submitted.Addendum#2: h11: this supplemental emdr is submitted to document additional information provided and to correct expiry date, manufacturing date.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per the medical records review, about 1 year 2 months post implant of bard pre-shaped mesh, patient had hematoma, abdominal pain thereby underwent repair with mesh removal.The instructions-for-use supplied with the device list hematoma as a possible complication.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
It is alleged by the patients attorney that on (b)(6) 2009, the patient underwent surgery for repair of an inguinal hernia.As reported, a bard/davol marlex reference number (b)(4), lot number husl1076 was implanted to repair the hernia defect.It is alleged that a year later on (b)(6) 2010, the patient underwent an additional surgery to repair the hernia defect and "remove it." as alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective marlex.Addendum per additional information provided: on (b)(6) 2009 - patient was diagnosed with right indirect inguinal hernia thereby underwent open repair with the implant of pre-shaped mesh.Per operative notes, ¿the hernia sac was separated from the cord structures, twisted and suture ligated at the peritoneal fold level.A flat piece of pre-shaped mesh was tailored to go on the top of hasselbach¿s triangle.The distal tip of the mesh was tacked doubly over the pubic tubercle with suture.The 2 tails of the mesh were wrapped around the cord at the internal ring area and were sutured to each other.Medial lateral sides of the mesh were tacked to the underlying fascia with suture.¿ on (b)(6) 2010 - patient was diagnosed with right inguinodynia, hematoma thereby underwent open repair with the removal of mesh.Per operative notes, ¿the mesh was dissected free from the scar in the superolateral direction and underlying tissue along the superior aspect of the conjoined tendon.Then, focused the attention along the shelving edge of the inguinal ligament.The mesh was dissected free away from the external oblique fibers along the inferior aspect.The mesh was retracted anteriorly and dissected free from the shelving edge of the inguinal ligament.Started dividing the mesh just before its attachments to the pubic tubercle.After partial division of the mesh, dissected that free sharply from the pubic tubercle.The spermatic cord and contents were passed around the pubic tubercle portion of the mesh, and then the inferior aspect of the mesh was dissected free completely from the shelving edges of the inguinal ligament.The mesh was removed.¿ attorney alleges that the patient had pain.

• Brand Name: BARD MESH PRE-SHAPED
• 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: 7124378
• Report Number: 1213643-2017-01048
• Device Sequence Number: 1410850
• Product Code: FTL
• UDI-Device Identifier: 00801741016547
• UDI-Public: (01)00801741016547
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2023

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 Expiration Date: 01/28/2014
• Device Model Number: 0112700
• Device Catalogue Number: 0112700
• Device Lot Number: HUSL1076
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 05/02/2018; 10/30/2023
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 05/07/2018; 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2009
• 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: Disability; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 73 KG