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

Catalog Number	0117170
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Hernia (2240)
Date of Event	12/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, infection, chronic pain and subsequent surgical intervention.The instructions-for-use (ifu) supplied with the device lists recurrence of hernia and infection as possible complications.In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." this emdr represents the bard/davol perfix light plug (device #3).Additional emdrs were submitted to represent the two bard/davol perfix plugs (device #1 and device #2) and the bard/davol ventralex st (device #4).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient was implanted with a bard/davol perfix plug in the course of an inguinal hernia repair surgery on (b)(6) 2008.It is alleged that further to the implantation with the product, the patient suffered the development of mesh failure, hernia recurrence, infection and chronic pain.Attorney alleges that the patient underwent a corrective revision surgery on (b)(6) 2010 and also on (b)(6) 2011.Attorney alleges that the patient underwent a corrective revision surgery with a bard/davol perfix plug on (b)(6) 2015.Attorney alleges that the patient underwent a corrective revision surgery on (b)(6) 2016.Attorney also alleges that the patient was implanted with another bard/davol perfix light plug (date unspecified).Attorney alleges that the patient underwent a corrective revision surgery with a bard/davol ventralex st mesh on (b)(6) 2017.It is alleged that the patient has suffered injuries, losses, and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences.Attorney alleges the patient suffered permanent injuries including scarring, disfigurement, suffering and physical disability.It is alleged that the patient continues to undergo medical care and treatment.It is also alleged that the device was defective.
Event or Problem Description
Attorney alleges that the patient was implanted with two bard/davol perfix plug in course of an inguinal hernia repair surgery on (b)(6) 2008.It is alleged that further to the implantation with the product, the patient suffered the development of mesh failure, hernia recurrence, infection and chronic pain.Attorney alleges that the patient underwent a corrective revision surgery on (b)(6) 2010 and also on (b)(6) 2011.Attorney alleges that the patient underwent a corrective revision surgery with bard/davol perfix plug light on (b)(6) 2015.Attorney alleges that the patient underwent a corrective revision surgery on (b)(6) 2016.Attorney alleges that the patient underwent a corrective revision surgery with bard/davol ventralex st on (b)(6) 2017.Attorney alleges that the patient has suffered injuries, losses, and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences.Attorney alleges that the patient suffered permanent injuries including scarring, disfigurement, hernia recurrence, infection and chronic pain.Attorney alleges that the patient had pain, suffering and disability.Attorney alleges that the patient continues to undergo medical care and treatment.Attorney also alleges that the patient sustained personal injury and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, infection, chronic pain and subsequent surgical intervention.The instructions-for-use (ifu) supplied with the device lists recurrence of hernia and infection as possible complications.In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." addendum: h.11: this supplemental emdr has been submitted to report the implant and event dates, which were omitted in the initial mdr (mdr no.1213643-2021-07511).This supplemental emdr represents the bard/davol perfix plug light (device #3).Additional supplemental emdrs were submitted to represent the two bard/davol perfix plugs (device #1 & device #2) and the bard/davol ventralex st (device #4).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.H3 other text : not returned.

• Brand Name: PERFIX PLUG LIGHT
• 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: 12457901
• Report Number: 1213643-2021-07511
• Device Sequence Number: 20018317
• Product Code: FTL
• UDI-Device Identifier: 00801741031007
• UDI-Public: (01)00801741031007
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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: 10/28/2016
• Device Catalogue Number: 0117170
• Device Lot Number: HUVI2068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 10/16/2021
• Initial Report FDA Received Date: 09/12/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2011
• 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: Male