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

Catalog Number	0112960
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Insufficient Information (4580)
Date of Event	02/10/2014
Type of Reportable Event	Death
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.This emdr represents the bard/davol perfix plug (device #1).Additional emdr's were submitted to represent the bard/davol ventralight st mesh (device #2) and bard/davol perfix plug (device #3).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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol perfix plug and ventralight st on (b)(6)2013 and/or (b)(6)2014 and/or (b)(6)2014.As reported, the patient is making a claim for an adverse patient outcome against all the 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 also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol perfix plug and ventralight st on (b)(6) 2013 and/or (b)(6) 2014 and/or (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against all the 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 also alleged that the patient experienced emotional distress and the device was defective.Addendum per legal claim: attorney alleges that the patient underwent surgery for the implant of unspecified bard/davol perfix plug on (b)(6) 2013 and ventralight st on (b)(6) 2014 and (b)(6) 2014.As reported, the plaintiff is making a claim for an adverse patient outcome against all 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¿.The attorney alleged that the patient passed away on (b)(6) 2022 and had "injuries, losses suffered prior to death as a result of defendants¿ wrongful conduct".It is also alleged that the plaintiff 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.This emdr represents the bard/davol perfix plug (device #1).Additional emdr's were submitted to represent the bard/davol ventralight st mesh (device #2) and bard/davol perfix plug (device #3).Addendum: h11: this is an addendum to the initial emdr submitted (mdr number 1213643-2023-091710).This supplemental emdr is being submitted to report the allegation of patient death.No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including death 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 plaintiff".No medical records, autopsy report, or death certificate have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This supplemental emdr represents the bard/davol perfix plug (device #1).Additional supplemental emdrs were submitted to represent the bard/davol ventralight st mesh (device #2).And bard/davol ventralight st mesh (device #3).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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol perfix plug and ventralight st on (b)(6) 2013 and/or (b)(6) 2014 and/or (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against all the 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 also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2013 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of perfix plug (device 1).Per operative notes, ¿recurrent hernia was identified at the superior aspect of old repair.A medium sized perfix plug (device 1) was anchored to the fascia superiorly and into the old synthetic mesh inferiorly using sutures.¿ (b)(6) 2014 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the removal of mesh (device 1) and implant of ventralight st (device 2).Per operative notes, ¿the old mesh (device 1) had pulled away from the fascia was somewhat contracted, therefore the old mesh was excised.A piece of ventralight st mesh (device 2) was placed to fill the defect using sutures.¿ (b)(6) 2014 ¿ patient was diagnosed with cellulitis, complex abdominal wound secondary to wound dehiscence thereby underwent excisional debridement of wound.(b)(6) 2014 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the removal of mesh (device 2) and implant of ventralight st mesh (device 3).Per operative notes, ¿the old mesh (device 2) was excised.The hernia defect were noted and a piece of ventralight st mesh (device 3) was anchored to lateral edge of fascia using sutures.¿ (b)(6) 2016 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair.Per operative notes, ¿the previous mesh (device 3) was intact.A synthetic mesh was placed to fix the defect using sutures.¿.
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 #1: h11: this is an addendum to the initial emdr submitted (mdr number 1213643-2023-091710).This supplemental emdr is being submitted to report the allegation of patient death.No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including death 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 plaintiff".No medical records, autopsy report, or death certificate have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum#2: h11: this supplemental emdr is submitted to document additional information provided and to correct date of event.Based on the medical record review, post implant of perfix plug (device #1), patient had hernia recurrence, mesh migration, mesh deformation thereby underwent laparoscopic repair with the removal of mesh (device #1).Per previous legal claim, it was mentioned that patient passed away on (b)(6) 2022.No information regarding patient¿s death in the medical records provided to date and no autopsy report, or death certificate have been provided.Note, the manufacturing date (15-oct-2012) is considered to be a best estimate.Updated fields: a2, b2, b4, b5, b6, b7, d1, d3, d4, d.6b (date of explant), g3, g6, h2, h4, h6, h10, h11.Corrected fields: b3 (date of event).This supplemental emdr represents the perfix plug (device #1).An additional supplemental emdr was submitted to represent the bard/davol ventralight st mesh (device #2, #3).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 PLUG
• 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: 16813407
• Report Number: 1213643-2023-091710
• Device Sequence Number: 14886453
• Product Code: FTL
• UDI-Device Identifier: 00801741016660
• UDI-Public: (01)00801741016660(17)171128(10)HUWJ2047
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• 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,Followup
• Report Date (Section B): 09/05/2025

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: 11/28/2017
• Device Catalogue Number: 0112960
• Device Lot Number: HUWJ2047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 07/11/2023; 08/15/2025
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 07/20/2023; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2012
• 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: Death; Disability; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male