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); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Insufficient Information (4580)
Date of Event	09/23/2019
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.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 an unspecified bard mesh (bard flat mesh) on (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against bard mesh (bard flat mesh).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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard mesh (bard flat mesh) on (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against bard mesh (bard flat mesh).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: (b)(6) 2014 - patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of bard pre-shaped mesh.Per operative notes, ¿hernia sac was identified and resected at its base.A bard pre-shaped mesh was placed and secured in place.¿ (b)(6) 2016 ¿ patient was diagnosed with right inguinal hernia and recurrent left inguinal hernia thereby underwent laparoscopic converted to open repair with implant of synthetic mesh.Per operative notes, ¿in the right side, lot of scar tissue was noted.The well-defined direct defect was noted and dissected and synthetic mesh was placed laparoscopically in the peritoneal space and sutured.In the left side open repair, ¿extensive scarring with previously placed bard pre-shaped mesh was noted and fascia was closed with sutures.¿ (b)(6) 2019 - patient was diagnosed with recurrent left inguinal hernia thereby underwent robot assisted laparoscopic repair with implant of synthetic mesh.Per operative notes, ¿large direct recurrent hernia was noted.The previously placed bard pre-shaped mesh was noted.The hernia had recurred just below the inferior edge of the mesh.Omental adhesions with scar tissue to mesh was lysed and new synthetic mesh was placed and sutured.¿ (b)(6) 2019 - patient was diagnosed with recurrent left inguinal hernia and seroma thereby underwent open repair with removal of all meshes and implant of synthetic mesh.Per operative notes, ¿direct recurrence with incarcerated fat was noted.Adhesions and scar tissues were removed and seroma was evacuated.The old meshes were removed and synthetic mesh was placed over the defect and sutured.¿.
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 and 510k number.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-jan-2013) is considered to be a best estimate.Updated fields: a2, a4, b2, b3, b4, b5, b7, d4, d.6b (date of explant), g3, g6, h2, h4, h6, h10, h11.Corrected fields: 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 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: 12843939
• Report Number: 1213643-2021-08771
• Device Sequence Number: 17231139
• Product Code: FTL
• UDI-Device Identifier: 00801741016554
• UDI-Public: (01)00801741016554(17)180128(10)HUXA0682
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: 01/28/2018
• Device Catalogue Number: 0112710
• Device Lot Number: HUXA0682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2013
• 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: Required Intervention; Disability
• Patient Age: 34 YR
• Patient Sex: Male