MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG; SURGICAL MESH

Catalog Number	0112760
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	11/06/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.This mdr represents the perfix plug (device 2).An additional supplemental emdr was submitted to represent the bard/davol flat mesh (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: on (b)(6) 2006 ¿ patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of bard flat mesh (device 1).Per op notes, ¿a indirect component of hernia sac was found on anteromedial aspect of cord.A piece of bard flat mesh (device 1) was placed in region of pubic tubercle using sutures.¿ on (b)(6) 2007 ¿ patient was diagnosed with left groin pain thereby underwent open repair with the partial removal of mesh (device 1) and implant of perfix plug (device 2).Per op notes, ¿the cord was adhesed down to inguinal floor and mesh.A large suture and redundant mesh at pubic tubercle were identified.There remained a significant defect between the remaining mesh (device 1) and pubic tubercle.A medium sized perfix plug (device 2) was placed in preperitoneal space and positioned beneath pubic tubercle using sutures.¿ on (b)(6) 2009 ¿ patient was diagnosed with right inguinal hernia, recurrent left inguinal hernia thereby underwent open repair with the removal of mesh (device 1, 2).Per op notes, ¿on right side, a large sized direct inguinal hernia was found.A large synthetic mesh was placed to cover the defect using sutures.On left side, there was lot of scarring and the mesh (device 1,2) was completely displaced was excised from the attachments.A direct inguinal hernia was noted.A small synthetic mesh was placed and sutured.¿.

• Brand Name: PERFIX PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 23441361
• Report Number: 1213643-2025-01051
• Device Sequence Number: 20068843
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608(10)43ARD757
• 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: 2007
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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 Catalogue Number: 0112760
• Device Lot Number: 43ARD757
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 45 YR
• Patient Sex: Male