MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Perfix Light Plug; Surgical Mesh

Catalog Number	0117080
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	03/21/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2009 - patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of kugel patch (device 1).Per op notes, ¿a transverse incision was made above the midportion of the left inguinal ligament.An indirect hernia sac was identified and reduced back into the peritoneum.A kugel patch (device 1) was placed into the preperitoneal pocket and secured with sutures.¿ (b)(6) 2010 - patient was diagnosed with recurrent left inguinal hernia, indirect type thereby underwent open repair with implant of perfix light plug (device 2).Per op notes, ¿an inguinal incision was made.An indirect sac was identified and cleared from medial to lateral.A perfix light plug (device 2) was placed into the preperitoneal space.The previously placed mesh (device 1) could be palpated along the cephalad border of the defect and the perfix light plug (device 2) was secured to this piece of mesh (device 1).¿ (b)(6) 2011 - patient was diagnosed with prostate cancer thereby underwent radical prostatectomy.Per op notes, ¿a midline incision was made.Left pelvic space was created and noted to have a mesh (device 1 and 2) which extends from the abdominal wall and the peritoneum were adherent to this mesh (device 1 and 2).The mesh (device 1 and 2) was overlying the left iliac vessels and the plane leriche was not able to be developed.Some thickening related to the mesh (device 1 and 2) in the left pelvic space was noted.A radical prostatectomy was performed.¿.
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 light plug (device 2).An additional supplemental emdr was submitted to represent the 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.

• Brand Name: Perfix Light 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 ; +1(800)556-6756
• MDR Report Key: 50021945
• Report Number: 1213643-2026-00940
• Device Sequence Number: 13406462
• Product Code: FTL
• UDI-Device Identifier: 00801741030970
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2026

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: 02/28/2012
• Device Catalogue Number: 0117080
• Device Lot Number: HUUA0785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2010
• 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 Sex: Male
• Patient Weight: 232 LB