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

Catalog Number	0112970
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	04/15/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient's attorney: on (b)(6) 2010 - patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1).Per operative notes, ¿there was a large direct hernia sac.An extra-large perfix plug (device #1) and onlay mesh graft were then secured using sutures.¿ on (b)(6) 2013 - patient was diagnosed with right direct & indirect inguinal hernias thereby underwent open repair with the implant of two perfix plug (device #2 & #3).Per operative notes, "a large direct hernia sac was identified and reduced into the preperitoneal space.An extra-large perfix plug (device #2) was secured into the inguinal ligament.There was a small indirect hernia, a large perfix plug (device # 3) was secured into the transversalis fascia.The onlay patch was then laid on the floor of the canal.¿ ni-ni-2013 to present - patient underwent pain management for severe and chronic pain in the groin.Ni-apr-2013 to ni-sep-2017 - patient had hernia complications.(b)(6) 2013 to ni-ni-2018 - patient had epidural steroid injection for cervical radicular pain.Attorney alleged that the patient had bowel obstruction, fistulae, infection, mesh migration, mesh shrinkage, pain, hernia recurrence, seroma, inflammation, constipation, irritation, painful sexual relations and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about a month post implant of perfix plug, patient was diagnosed with hernia and pain thereby underwent treatment.The instructions-for-use supplied with the device lists hernia recurrence and pain as possible complications.Review of manufacturing records shows product was manufactured to specification.Note, the manufacturing date (15-apr-2012) and event date (15-apr-2013) are considered to be a best estimate.This emdr represents the perfix plug (device #3).Additional supplemental emdr's were submitted to represent the 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.

• 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: 21264834
• Report Number: 1213643-2025-090042
• Device Sequence Number: 15805746
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677(17)170428(10)HUWD1433
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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: 04/28/2017
• Device Catalogue Number: 0112970
• Device Lot Number: HUWD1433
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2012
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 98 KG