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

Catalog Number	0113700
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994); Hernia (2240); Disability (2371)
Date of Event	12/08/2012
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.Based on the limited information provided at this time, no conclusions can be made.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.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 an inguinal hernia.A bard/davol flat mesh, reference number 0113700, lot number huuf1260 was implanted to repair the hernia defect.On (b)(6) 2012: the patient underwent an additional surgery for recurrence repair.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
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.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct brand name and manufacturing date.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 1 year and 2 months post implant of bard mesh pre-shaped, patient was diagnosed with hernia recurrence and abdominal pain thereby underwent repair.Review of manufacturing records confirms product was manufactured to specification.Updated fields: a2, b4, b5, b7, d4 (udi no), e3, g1, g3, g6, h2, h6, h10, h11.Corrected fields: d1 (brand name) and h4 (manufacturing date).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
The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent surgery for repair of an inguinal hernia.A bard/davol flat mesh, reference number (b)(4), lot number huuf1260 was implanted to repair the hernia defect.(b)(6) 2012: the patient underwent an additional surgery for recurrence repair.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: (b)(6) 2011 - patient was diagnosed with incarcerated indirect right inguinal area thereby underwent open repair with implant of bard mesh pre-shaped (device #1).Per operative notes, ¿the hernia sac was completely free from the cord structures to the internal ring.A large pre-shaped mesh was placed in the inguinal canal and secured to the pubic tubercle region.¿ (b)(6) 2012 - patient was diagnosed with incarcerated and recurrent right inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device #2).Per operative notes, ¿identified a recurrent indirect hernia sac which also appeared to contain the appendix.The hernia sac was completely dissected free and a large 3dmax mesh was placed in the preperitoneal space.¿ (note, there was no mention/visualization of bard mesh pre-shaped during this repair).Attorney alleges that the patient had pain, infection, hernia recurrence and emotional injuries.

• 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: 7288392
• Report Number: 1213643-2018-00349
• Device Sequence Number: 1741914
• Product Code: FTL
• UDI-Device Identifier: 00801741030697
• UDI-Public: (01)00801741030697(17)150828(10)HUUF1260
• 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): 09/24/2024

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: 08/28/2015
• Device Catalogue Number: 0113700
• Device Lot Number: HUUF1260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2010
• 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: 61 YR
• Patient Sex: Male