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

Catalog Number	0112700
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Disability (2371)
Date of Event	03/06/2015
Type of Reportable Event	Serious Injury
Additional 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.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr 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
The following was alleged by the patient's attorney: on (b)(6) 2011: the patient underwent surgery for repair of a right inguinal hernia.A bard/davol mesh pre-shaped, reference number 0112700, was implanted to repair the hernia defect.On (b)(6) 2015: the patient underwent an additional surgery to repair recurrent right inguinal hernia.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.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent surgery for repair of a right inguinal hernia.A bard/davol mesh pre-shaped, reference number 0112700, was implanted to repair the hernia defect.(b)(6) 2015: the patient underwent an additional surgery to repair recurrent right inguinal hernia.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 medical records provided: (b)(6) 2011 - patient was diagnosed with direct right inguinal hernia thereby underwent open repair with the implant of bard mesh pre-shaped.Per operative notes, ¿the hernia was obviously protruding out through the ring.The hernia was reduced back into the preperitoneal space at the floor of inguinal canal and repaired using sutures.With the floor repaired and hernia reduced, a bard mesh pre-shaped was then shaped into a piece of mesh flexible arrowhead, applied it to the floor of the inguinal canal along the lower of the inguinal ligament on the anterior surface of the internal oblique musculature using sutures.The mesh extended out to the inferior epigastric vessels and the mouth of the internal inguinal ring, which had been tightened up with repair of the floor.¿ (b)(6) 2015 - patient was diagnosed with recurrent right inguinal hernia thereby underwent lichtenstein repair with implant of synthetic mesh.Per operative notes, ¿opened up the external oblique aponeurosis in the direction of its fibers and dissected the cord free from the shelving edge.Patient did not have mesh placed at this time and then separated the hernia sac from the cord and cord structures which was indirect.A synthetic mesh was placed.¿ (note: there is no visualization of bard mesh pre-shaped in this operative note and no other operative notes were provided).Attorney alleges that the patient had hernia recurrence, pain and emotional injuries.
Additional 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.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 3 years 4 months post implant of bard mesh pre-shaped, patient was diagnosed with hernia recurrence thereby underwent additional surgery.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Updated fields: a2, b4, b5, d4 (corporate lot no), e3, g1, g3, g6, h2, h4, h6, h10.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
• 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: 7247944
• Report Number: 1213643-2018-00214
• Device Sequence Number: 2378298
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: 10/28/2015
• Device Catalogue Number: 0112700
• Device Lot Number: HUUJ0435
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2010
• 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: 59 YR
• Patient Sex: Male