MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. KUGEL PATCH; SURGICAL MESH

Catalog Number	0010102
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Insufficient Information (4580)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges that the patient underwent subsequent surgical intervention for removal of dense adhesion 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 adhesion as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the bard/davol kugel patch (device #2).An additional emdr was submitted to represent the bard/davol kugel patch (device #1).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of two unspecified bard/davol kugel hernia patches on (b)(6) 2006.As reported, the patient is making a claim for an adverse patient outcome against the 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 alleged that the patient underwent surgery and removal of dense adhesions on (b)(6) 2019.It is also alleged that the patient experienced emotional distress and the device was defective.

• Brand Name: KUGEL PATCH
• 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: 15115573
• Report Number: 1213643-2022-95637
• Device Sequence Number: 12128721
• Product Code: FTL
• UDI-Device Identifier: 00801741016349
• UDI-Public: (01)00801741016349
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2022

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: 04/28/2008
• Device Catalogue Number: 0010102
• Device Lot Number: 43DND289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2003
• 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 Sex: Female