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 Codes	Adhesion(s) (1695); Inflammation (1932); Pain (1994)
Date of Event	05/21/2007
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 11 months post implant of perfix plug, patient was diagnosed with adhesions, inflammation and pain thereby underwent repair with mesh removal.The instructions-for-use supplied with the device lists adhesions and inflammation as possible complications.This emdr represents perfix plug (device #2).An additional supplemental emdr was submitted to represent kugel patch (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.
Event or Problem Description
Per additional information provided: (b)(6) 2006 - patient was diagnosed with reducible left inguinal hernia thereby underwent open repair with implant of kugel patch (device #1) and perfix plug(device #2).Per operative notes, ¿there was a large direct defect encompassing the entire floor of the inguinal canal.A kugel patch (device #1) was placed in the preperitoneal space, and the repair was reinforced with a keyhole mesh (perfix plug ¿ device #2) laid across transversalis fascia.The mesh was secured laterally to the shelving edge of the inguinal ligament and medially to the conjoined tendon.¿ (b)(6) 2007 - patient was diagnosed with chronic left inguinal pain thereby underwent open repair with removal of mesh (device #1 & #2).Per operative notes, ¿ the previously placed mesh (device #1, #2) was densely adherent to the preperitoneal tissues and had mediated a dense inflammatory reaction along the entire length of the inguinal floor.This was dissected free and separated the mesh off the underlying fatty tissue.The mesh was removed completely from the peritoneal space.¿ attorney alleges that the patient had adhesions, pain, nerve damage and hernia recurrence.

• 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: 20723720
• Report Number: 1213643-2024-094820
• Device Sequence Number: 6583567
• Product Code: FTL
• UDI-Device Identifier: 00801741016684
• UDI-Public: (01)00801741016684(10)43HPD215
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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 Catalogue Number: 0112980
• Device Lot Number: 43HPD215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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