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

Catalog Number	0117180
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Inflammation (1932); Hernia (2240); Fibrosis (3167)
Date of Event	01/07/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 7 months post implant of perfix plug light, patient was diagnosed with hernia recurrence, fibrosis and inflammation thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence and inflammation as possible complications.This emdr represents the perfix plug light (device #3).Additional supplemental emdr's were submitted to represent the perfix plug light (device #1) and perfix plug light (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.
Event or Problem Description
Per additional information provided: (b)(6) 2010 - patient was diagnosed with left direct inguinal hernia thereby underwent open repair with the implant of perfix light plug (device #1).Per operative notes, ¿the hernia sac was dissected off.A perfix light plug (device #1) was placed at the level of pubic tubercle and secured by tackers.¿ (b)(6) 2013 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of two perfix light plug (device #2 and device #3).Per operative notes, ¿previously placed perfix light plug (device #1) was identified.There was a small defect at the pubic tubercle then a perfix light plug (device #3) was placed as an onlay mesh using sutures.A perfix light plug (device #2) was placed through the internal inguinal ring and secured by staples.¿ (b)(6) 2014 - patient was diagnosed with recurrent left direct inguinal hernia thereby underwent laparoscopic repair with the removal of two perfix light plug (device #1) and (device #3) and implant of synthetic mesh.Per operative notes, ¿a large left direct inguinal hernia was identified.A perfix light plugs (device #1) and (device #3) were protruding and wadded up in a ball were removed.A synthetic mesh was placed over the defect using tackers.¿ (there was no visualization/mention of perfix light plug (device #2)) (b)(6) 2015 - patient was diagnosed with recurrent left inguinal hernia thereby underwent repair with the implant of perfix plug (device #4) and synthetic mesh.(note: no operative notes and no visualization/mention of perfix light plug (device #2) were provided.) attorney alleges that the patient had adhesions, mesh migration, nerve damage, pain, hernia recurrence, vas deferens resection and emotional injuries.
Event or Problem Description
Per information provided by the patient's attorney: (b)(6) 2010 - patient was diagnosed with left direct inguinal hernia thereby underwent open repair with the implant of perfix light plug (device #1).Per operative notes, ¿the hernia sac was dissected off.A perfix light plug (device #1) was placed at the level of pubic tubercle and secured by tackers.¿ (b)(6) 2013 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of two perfix light plug (device #2 and device #3).Per operative notes, ¿previously placed perfix light plug (device #1) was identified.There was a small defect at the pubic tubercle then a perfix light plug (device #3) was placed as an onlay mesh using sutures.A perfix light plug (device #2) was placed through the internal inguinal ring and secured by staples.¿ (b)(6) 2014 - patient was diagnosed with recurrent left direct inguinal hernia thereby underwent laparoscopic repair with the removal of two perfix light plug (device #1) and (device #3) and implant of synthetic mesh.Per operative notes, ¿a large left direct inguinal hernia was identified.A perfix light plugs (device #1) and (device #3) were protruding and wadded up in a ball were removed.A synthetic mesh was placed over the defect using tackers.¿ (there was no visualization/mention of perfix light plug (device #2)).(b)(6) 2015 - patient was diagnosed with recurrent left inguinal hernia thereby underwent repair with the implant of perfix plug (device #4) and synthetic mesh.(note: no operative notes and no visualization/mention of perfix light plug (device #2) were provided.) attorney alleges that the patient had adhesions, mesh migration, nerve damage, pain, hernia recurrence, vas deferens resection and emotional injuries.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 7 months post implant of perfix plug light, patient was diagnosed with hernia recurrence, fibrosis, inflammation, extrusion and material deformation thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence and inflammation as possible complications.Addendum: h11: this supplemental emdr is submitted to update manufacturing date and to correct the outcomes attributed to adv ev and date of explant.Note, the manufacturing date (15-feb-2013) is considered to be a best estimate.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Updated fields: b4, g3, g6, h2, h4, h6, h10, h11.Corrected fields: b2 (outcomes attributed to adv ev), d.6b (date of explant).This supplemental emdr represents the perfix plug light (device #3).An additional supplemental emdrs were submitted to represent the perfix plug light (device #1, #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.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: 20722743
• Report Number: 1213643-2024-094819
• Device Sequence Number: 12401077
• Product Code: FTL
• UDI-Device Identifier: 00801741031014
• UDI-Public: (01)00801741031014(17)180228(10)HUXB0161
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 12/26/2024

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: 02/28/2018
• Device Catalogue Number: 0117180
• Device Lot Number: HUXB0161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2013
• 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: Required Intervention; Disability
• Patient Age: 57 YR
• Patient Sex: Male