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

Catalog Number	0112980
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	12/10/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per medical records: (b)(6) 2015- patient was diagnosed with symptomatic right inguinal hernia thereby underwent open repair with the implant of bard preshaped mesh (device #1) and perfix plug (device #2).Per operative notes, ¿a large deep direct hernia sac was reduced.An extra-large perfix plug (device #1) was sutured to shelving edge of poupart¿s ligament inferiorly and pubic tubercle medially and underneath the conjoint tendon.The onlay bard preshaped patch (device #2) was placed and sutured.¿ (b)(6) 2015- patient was diagnosed with recurrent symptomatic right inguinal hernia thereby underwent robotic repair with the partial removal of mesh (device #2).Per operative notes, ¿there was a small left indirect and direct inguinal hernia.There was a recurrent right direct inguinal hernia.Previous mesh (device #2) was encountered.The marlex mesh (device #2) was not dissected out completely.The hernia was reduced and closed using suture.The defect was reinforced with a medium 3dmax mesh (device #3).A notch was cut out to incorporate the previous mesh as well as keyhole (device #1) repair.The mesh covered the defect completely.¿ attorney alleges that the patient had pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 8 months post implant of perfix plug, patient was diagnosed with hernia recurrence thereby underwent revision surgery.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.Review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-jun-2013) is considered to be a best estimate.This emdr represents the bard/davol perfix plug (device #2).An additional supplemental emdr was submitted to represent the bard mesh pre-shaped w/ keyhole (device #1).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
• 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: 21729220
• Report Number: 1213643-2025-090142
• Device Sequence Number: 20989146
• Product Code: FTL
• UDI-Device Identifier: 00801741016684
• UDI-Public: (01)00801741016684(17)180628(10)HUXF0039
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

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: 06/28/2018
• Device Catalogue Number: 0112980
• Device Lot Number: HUXF0039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2013
• 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
• Patient Age: 86 YR
• Patient Sex: Male