MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH; SURGICAL MESH

Catalog Number	0112640
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Insufficient Information (4580)
Date of Event	03/08/2021
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.Should additional information be provided, a supplemental emdr will be submitted.Device not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard mesh (bard flat mesh) patch on (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against the 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.
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: this supplemental emdr is submitted to document additional information provided.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-nov-2019) is considered to be a best estimate.This supplemental emdr represents the bard flat mesh (device #1).An additional emdr was submitted to represent the bard/davol ventralight st mesh using echo ps (device #2).Updated fields: a2, b2, b3, b4, b5, b7,d3, d4 (catalog no, lot no, expiry date, udi), 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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard mesh (bard flat mesh) patch on (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against the 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: 25-sep-2020 - patient was diagnosed with incisional hernia at right upper quadrant thereby underwent open repair with the implant of bard flat mesh (device #1).Per operative notes, "the hernia was identified lateral to rectus.The fascia was closed and a bard flat mesh (device #1) was placed and sutured." (b)(6) 2021 - patient was incisional hernia without obstruction and adhesions thereby underwent laparoscopic repair with the implant of ventralight st mesh using echo ps (device #2).Per operative notes, "a palpable region of fascial weakness in right upper quadrant was noted.A ventralight st mesh using echo ps(device #2) was placed and tacked." (note: there was no mention/visualization of the previously placed bard flat mesh (device #1) during this procedure) (b)(6) 2022 - patient was diagnosed with recurrent ventral incisional hernia at right upper quadrant and scar tissue thereby underwent open repair with the implant of phasix st mesh (device #3).Per operative notes, "the edge of a previous mesh (device #2) repair was seen.The hernia was just inferior edge of this.A phasix st mesh (device #3) was sutured.".

• Brand Name: BARD FLAT MESH
• 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: 16363326
• Report Number: 1213643-2023-090664
• Device Sequence Number: 12610193
• Product Code: FTL
• UDI-Device Identifier: 00801741016493
• UDI-Public: (01)00801741016493(17)241028(10)HUDY0311
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 10/28/2024
• Device Catalogue Number: 0112640
• Device Lot Number: HUDY0311
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• 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: 52 YR
• Patient Sex: Female