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

Catalog Number	0112980
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Fibrosis (3167)
Date of Event	01/22/2019
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-dec-2013) is considered to be a best estimate.This emdr represents the perfix plug (device #2).An additional supplemental emdr was submitted to represent the perfix plug (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) 2018 - patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of 2x perfix plug (device #1, #2).Per operative notes, ¿an indirect hernia sac was identified and dissected.The contents of the sac were reduced and excised.2x perfix plug (device #1, #2) were placed and sutured.(b)(6) 2019 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with excision of perfix plug (device #1, #2) and implant of synthetic mesh.Per operative notes, ¿a direct and indirect hernia defect were identified, and the contents were reduced.The previous meshes (device #1& #2) were encountered and excised.A synthetic mesh was placed and sutured.¿ (b)(6) 2019 - patient was diagnosed with recurrent right inguinal hernia thereby underwent robotic converted to open repair with implant of 3dmax (device #3) and perfix plug (device #4).Per operative notes, ¿the dense adhesions were taken down.The hernia defect was identified and reduced.A 3dmax (device #3) and perfix plug (device #4) were 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: 22084544
• Report Number: 1213643-2025-00410
• Device Sequence Number: 8059930
• Product Code: FTL
• UDI-Device Identifier: 00801741016684
• UDI-Public: (01)00801741016684(17)181228(10)HUXL0186
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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: 12/28/2018
• Device Catalogue Number: 0112980
• Device Lot Number: HUXL0186
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2013
• 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: 72 YR
• Patient Sex: Male