MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PERFIX LIGHT PLUG; SURGICAL MESH

Catalog Number	0117070
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Nerve Damage (1979); Pain (1994); Hernia (2240); Injury (2348); Disability (2371); Obstruction/Occlusion (2422); Bowel Perforation (2668); Fibrosis (3167)
Date of Event	10/06/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cause of the patient's post-op complications cannot be determined at this time.The patient's attorney alleges unspecified injuries and subsequent surgery; however, no details have been provided regarding the nature of the injury or surgery.No medical records have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.Note: no sample returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2013: the patient underwent surgery for implant of an unspecified bard/davol perfix plug light.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the 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.¿.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2013: the patient underwent surgery for implant of an unspecified bard/davol perfix plug light.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the 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.¿ addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with multiple ventral incisional hernia thereby underwent repair with implant of perfix light plug.(b)(6) 2014 - patient was diagnosed with small ventral incisional hernia there by underwent exploration abdominal with explanation of perfix light plug.(b)(6) 2017 - patient was diagnosed with recurrent ventral incisional hernia there by underwent for repair.Attorney alleges that the patient had adhesions, bowel obstruction, bowel perforation, mesh shrinkage, hernia recurrence, fibrotic, inflammed tissue surrounding the mesh, pain and suffering.The stress, severe pain and discomfort resulting from the mesh prevented plaintiff from sleeping well.She had suffered from fever, diarrhea, nausea and vomiting as a result of the bard mesh device.The plaintiff further suffers from the stress and anxiety caused by the pain as well as the pending abdominal reconstructive surgery that is necessary due to the failed bard hernia mesh implant.The failed hernia mesh implant drastically changed plaintiff's life and substantially decreased her ability to enjoy life.
Additional Manufacturer Narrative
The cause of the patient's post-op complications cannot be determined at this time.The patient's attorney alleges unspecified injuries and subsequent surgery; however, no details have been provided regarding the nature of the injury or surgery.No medical records have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 9 months post implant of perfix light plug, patient was diagnosed with bowel perforation, nerve damage, hernia recurrence, obstruction, fibrosis and adhesions thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence, pain and adhesions as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-jun-2012) is considered to be a best estimate.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.

• Brand Name: PERFIX LIGHT PLUG
• 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: 8169665
• Report Number: 1213643-2018-04807
• Device Sequence Number: 1697070
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963(17)170728(10)HUWF2503
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: 07/28/2017
• Device Catalogue Number: 0117070
• Device Lot Number: HUWF2503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2012
• 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; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Female