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

Catalog Number	0117080
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	02/17/2014
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.Note, the manufacturing date (15-jan-2012) is considered to be a best estimate.This emdr represents the bard perfix plug light (device 2).An additional supplemental emdr was submitted to represent the bard ventrio 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 information provided: (b)(6) 2010 - patient was diagnosed with umbilical hernia thereby underwent open repair with the implant of ventrio mesh (device 1).Per operative notes, ¿hernia sac was dissected out.A ventrio mesh (device 1) was placed into the abdominal wall and secure it with suture.¿ (b)(6) 2012 - patient was diagnosed with right indirect inguinal hernia thereby underwent open repair with explant of perfix plug light mesh (device #2).Per operative notes, ¿hernia sac was dissected out.A perfix light plug mesh (device 2) was placed into the preperitoneal space and secure it with suture.¿ (b)(6) 2014 - patient was diagnosed with recurrent right inguinal hernia, pain, adhesion thereby underwent laparoscopic repair with explant of perfix plug light mesh (device 2) and implant of one physio mesh.Per operative notes, ¿hernia sac was dissected out.Perfix plug light mesh (device 2) was removed totally.One physio mesh was placed into the inguinal side and secure it with suture.¿.

• 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 ; 8005566756
• MDR Report Key: 22975576
• Report Number: 1213643-2025-00815
• Device Sequence Number: 12996282
• Product Code: FTL
• UDI-Device Identifier: 00801741030970
• UDI-Public: (01)00801741030970(17)170128(10)HUWA0666
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2025

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: 01/28/2017
• Device Catalogue Number: 0117080
• Device Lot Number: HUWA0666
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2012
• 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: 48 YR
• Patient Sex: Male