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

Catalog Number	0117050
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol perfix plug (device #1) used to treat the patient.The patient's attorney did not allege a specific device failure or patient adverse event, and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard perfix plug (device #1).An additional emdr was submitted to represent the bard perfix plug (device #2).The patient's attorney did not make any allegations regarding the implanted bard soft mesh device.Note: the information provided by bard 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 bard.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on(b)(6) 2016: the patient underwent surgery implant of two unspecified bard/davol perfix plugs (device #1 and device #2).On (b)(6) 2017: the patient underwent surgery for implant of an unspecified bard/davol soft mesh.As reported, the patient is only making a claim for an adverse patient outcome against the bard perfix plugs (device #1 and device #2).As reported, the attorney alleges general allegations against the bard perfix plugs 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) 2016: the patient underwent surgery implant of two unspecified bard/davol perfix plugs (device #1 and device #2).(b)(6) 2017: the patient underwent surgery for implant of an unspecified bard/davol soft mesh.As reported, the patient is only making a claim for an adverse patient outcome against the bard perfix plugs (device #1 and device #2).As reported, the attorney alleges general allegations against the bard perfix plugs 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) 2016 - patient was diagnosed with bilateral inguinal hernia thereby underwent repair with the implant of perfix light plug (device #1 - left side) and perfix plug (device #2 - right side).(there were no operative notes provided in medical record) (b)(6) 2017 - patient was diagnosed with recurrent bilateral inguinal hernia and pain thereby underwent open repair with removal of perfix light plug (device #1 - left side), perfix plug (device #2 - right side) and implant of bard soft mesh (device #3).Per operative notes, ¿perfix light plug (device #1) and perfix plug (device #2) were more densely adherent and scarred on both sides of the inguinal ligament.Perfix plug (device #2) which was placed underlying conjoined tendon and the lower flap from the inguinal ligament was removed.Then a bard soft mesh (device #3) was placed and secured to the pubic tubercle by using sutures.Same removal procedure was performed in left side.Perfix light plug (device #1) was removed, and light weight unknown mesh was placed and sutured to the pubic tubercle.¿ attorney alleges that the patient had adhesions, mesh shrinkage, nerve damage and pain.It was also alleged that the patient had scarring, testicular and inguinal edema, left testicle raised and surgeon was unable to descend it appropriately, suggesting a chronic problem; spermatic cord was congested and bunched up in the distal inguinal canal; the left epigastric nerve and ilioinguinal nerves were not visualized during the procedure due to involvement in the mesh contraction, some of mesh needed to be removed in a piecemeal fashion.
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol perfix plug (device #1) used to treat the patient.The patient's attorney did not allege a specific device failure or patient adverse event, and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the brand name.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 1 years 8 months post implant of perfix plug light, patient was diagnosed with hernia recurrence, adhesions, scar tissue and pain thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence, adhesions and pain 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-aug-2014) is considered to be a best estimate.This supplemental emdr represents the perfix plug light (device #1).Additional supplemental emdr was submitted to represent the perfix plug (device #2).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 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: 7435904
• Report Number: 1213643-2018-01095
• Device Sequence Number: 1314330
• Product Code: FTL
• UDI-Device Identifier: 00801741030949
• UDI-Public: (01)00801741030949(17)190828(10)HUYH0847
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 08/28/2019
• Device Catalogue Number: 0117050
• Device Lot Number: HUYH0847
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2014
• 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 Age: 40 YR
• Patient Sex: Male
• Patient Weight: 64 KG