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

Catalog Number	0117070
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	04/02/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2010 - patient was diagnosed with reducible left inguinal hernia, umbilical hernia thereby underwent open repair with the implant of perfix plug (device 1).Per op notes, "the left groin was addressed.A small hernia was freed all the way down to internal ring.The inguinal ring was slightly patulous and a large perfix plug (device 1) was placed into the internal ring.An onlay patch was placed around the spermatic cord structures using sutures.The umbilical hernia was noted.The defect was closed using sutures." (b)(6) 2012 - patient was diagnosed with left recurrent inguinal hernia thereby underwent laparoscopic converted to open repair with the implant of perfix light plugs (device 2 and device 3).Per op notes, "the mesh plug (device 1) was completely stuck with down to the surrounding tissues with severe tissue reaction.The mesh reaction was noted.An direct hernia was identified.The floor was thickened from reaction, so a large perfix light plug (device 2) was placed into the area.The internal ring was surrounded by old mesh (device 1).A small portion of the perfix light plug (device 3) was placed and secured to assure the recurrence of indirect component using sutures." (b)(6) 2014 - patient was diagnosed with recurrent left inguinal hernia thereby underwent robotic assisted laparoscopic repair with the implant of synthetic mesh.Per op notes, "there was a recurrent left direct hernia.The previously placed plug (device 1, 2, 3) in left indirect space was noted.The indirect space was quite scarred.The direct hernia was reduced.A piece of synthetic mesh was cut to fit the space and covered the direct hernia using sutures.".
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-feb-2012) is considered to be a best estimate.This emdr represents the bard perfix plug (device 2).Additional supplemental emdr and emdr were submitted to represent the bard perfix plug (device 1 & 3).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 LIGHT
• 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: 25679134
• Report Number: 1213643-2026-00840
• Device Sequence Number: 15880370
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963(17)170228(10)HUWB0522
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: 02/28/2017
• Device Catalogue Number: 0117070
• Device Lot Number: HUWB0522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2012
• 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: 38 YR
• Patient Sex: Male