MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 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); Migration (4003)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Injury (2348); Disability (2371); Fibrosis (3167)
Date of Event	09/27/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The attorney alleges that the patient had unspecified injuries and corrective surgery; however, no details have been provided.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges per short form (see attached) that the patient underwent surgery for implant of an unspecified bard/davol bard mesh on (b)(6) 2013.It is also alleged by patient's attorney that on (b)(6) 2013, the patient had unspecified injuries related to a defect in the bard mesh, and underwent corrective surgery.As reported, the patient is making a claim for an adverse patient outcome against the bard mesh.As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.".
Event or Problem Description
Attorney alleges per short form (see attached) that the patient underwent surgery for implant of an unspecified bard/davol bard mesh on (b)(6) 2013.It is also alleged by patient's attorney that on (b)(6) 2013, the patient had unspecified injuries related to a defect in the bard mesh and underwent corrective surgery.As reported, the patient is making a claim for an adverse patient outcome against the bard mesh.As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." addendum per additional information provided: on (b)(6) 2013 ¿ patient was diagnosed with right indirect incarcerated inguinal hernia thereby underwent laparoscopic to open repair with the implant of bard mesh pre-shaped.Per op notes, ¿on the right, a very lateral indirect inguinal hernia was repaired using bard mesh pre-shaped and sutured.¿ on (b)(6) 2013 ¿ patient was diagnosed with ilioinguinal neuritis thereby underwent open repair.Per op notes, ¿the bard mesh pre-shaped was producing a significant of fibrosis and retraction.The ilioinguinal nerve anterior to the mesh involved fibrotic reaction was removed.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made.The attorney alleges that the patient had unspecified injuries and corrective surgery; however, no details have been provided.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct sex of patient, brand name, pma/510(k) #.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-apr-2012) is considered to be a best estimate.Updated fields: a2, b4, b5, b6, b7, d3, d4, g1, g3, g6, h2, h4, h6, h10, h11.Corrected fields: a3 (sex of patient), d1 (brand name), g4 (pma/510(k) #).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. -1213643; 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: 9396050
• Report Number: 1213643-2019-11587
• Device Sequence Number: 11425298
• Product Code: FTL
• UDI-Device Identifier: 00801741016547
• UDI-Public: (01)00801741016547(17)170428(10)HUWD1240
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 04/28/2017
• Device Catalogue Number: 0112700
• Device Lot Number: HUWD1240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2012
• 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: 53 YR
• Patient Sex: Female