MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD MESH PRE-SHAPED W/ KEYHOLE; SURGICAL MESH

Catalog Number	0112710
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Hernia (2240); Insufficient Information (4580)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard flat mesh (device #1).Additional emdr was submitted to represent the bard/davol perfix plug (device #2).Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard mesh (bard flat mesh) and bard/davol perfix plug on (b)(6) 2015 (x2).As reported, the patient is making a claim for an adverse patient outcome against both devices.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.¿ it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the brand name.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-2015) is considered to be a best estimate.Updated fields: a2, b2, b3, b4, b5, b6, b7, d3, d4 (catalog number, lot number, udi, expiry date), g3, g6, h2, h4, h6, h10., h11.Corrected fields: d1 (brand name) this supplemental emdr represents the bard mesh pre-shaped using keyhole (device 2).Additional supplemental emdr was submitted to represent the bard/davol perfix plug (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.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.H11: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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard mesh (bard flat mesh) and bard/davol perfix plug on (b)(6) 2015 (x2).As reported, the patient is making a claim for an adverse patient outcome against both devices.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.¿ it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: on (b)(6) -2015- patient was diagnosed with left inguinal hernia, thereby underwent open repair with implant of perfix plug (device 1) and bard mesh pre-shaped using keyhole (device 2).Per op notes, ¿the hernia sac was identified in the left inguinal region and was dissected.An indirect hernia was also identified and the contents are pushed into the peritoneal cavity.A perfix plug (device 1) was placed into the indirect hernia defect and sutured.A bard mesh pre-shaped using keyhole (device 2) was placed and sutured to the pubic tubercle medially along the ilioinguinal ligament inferiorly.¿.On (b)(6) 2021- patient was diagnosed with recurrent left inguinal hernia with pain, thereby underwent laparoscopic repair with implant of perfix plug (device 3).Per op notes, ¿extensive scar tissue from previous hernia with some wadded up mesh (device 1 and 2) that was involved in scar tissue.The hernia was identified and a large perfix plug and patch (device 3) was placed in the defect and sutured¿.

• Brand Name: BARD MESH PRE-SHAPED W/ KEYHOLE
• 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: 12186529
• Report Number: 1213643-2021-06308
• Device Sequence Number: 5904399
• Product Code: FTL
• UDI-Device Identifier: 00801741016554
• UDI-Public: (01)00801741016554(17)200328(10)HUZD0220
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 03/28/2020
• Device Catalogue Number: 0112710
• Device Lot Number: HUZD0220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 07/18/2021
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• 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: 64 YR
• Patient Sex: Male