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

Catalog Number	0112770
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069)
Date of Event	10/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about a year post implant of perfix plug, patient was diagnosed with infection and seroma thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists seroma and infection as possible complications.In regard to infection the warning section of 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." review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-apr-2015) is considered to be a best estimate.This emdr represents the bard/davol perfix plug (device #3).Additional supplemental emdr's were submitted to represent bard/davol perfix plug (device #1) and 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.
Event or Problem Description
Per information provided by patient's attorney: (b)(6) 2015 - patient was diagnosed with bilateral inguinal scrotal hernias thereby underwent open repair with implant of three perfix plug (left - device #1 & device #2, right - device #3).Per operative notes,¿ as testicle was intimately associated with the hernia sac, orchiectomy was performed.The incarcerated sigmoid colon freed from the surrounding hernia sac and placed with two large perfix plug (device #1 & device #2) and sutured.After the plug placement, extra large patch was placed in the floor of the inguinal canal.To the right, a large perfix plug (device #3) was placed to the floor of the inguinal canal and tacked.¿ (b)(6) 2016 - patient was diagnosed with infected mesh thereby underwent open repair with explant of all the perfix plug (left - device #1 & device #2, right - device #3).Per operative notes, "seroma and chronic drainage were noted around the previously placed mesh.The indurated tissue and mesh (device #3) were removed.On the left side similar debridement was performed and mesh (device #1 & device #2) explanted.Attorney alleged that the patient had abscess, infection, pain, hernia recurrence and emotional injuries.

• Brand Name: PERFIX 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: 21908872
• Report Number: 1213643-2025-090174
• Device Sequence Number: 4085159
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615(17)200328(10)HUZD0163
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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: 03/28/2020
• Device Catalogue Number: 0112770
• Device Lot Number: HUZD0163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• 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
• Patient Age: 47 YR
• Patient Sex: Male