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

Catalog Number	0117015
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erosion (1750); Inflammation (1932); Pain (1994); Hernia (2240); Insufficient Information (4580)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol perfix plug on (b)(6) 2010 and bard soft mesh pre-shaped on (b)(6) 2021.As reported, the patient is making a claim for an adverse patient outcome against both the devices.Attorney alleges the mesh products "were determined to have failed, causing chronic inflammation, adherence, erosion and recurrent hernias, and removed" on (b)(6) 2022.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 that the patient had chronic inflammation, adhesions, erosion, hernia recurrence and underwent subsequent surgical intervention to remove the mesh and "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.The instructions-for-use supplied with the device lists adhesions, hernia recurrence and inflammation as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard soft mesh pre-shaped w/ keyhole (device #2).An additional emdr was submitted to represent the perfix plug (device #1).Should additional information be provided, a supplemental emdr will be submitted.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.Not returned.

• Brand Name: BARD SOFT MESH PRE-SHAPED W/ KEYHOLE
• 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: 20912512
• Report Number: 1213643-2024-094855
• Device Sequence Number: 18089690
• Product Code: FTL
• UDI-Device Identifier: 00801741030925
• UDI-Public: (01)00801741030925
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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 Catalogue Number: 0117015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male