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

Catalog Number	0117070
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during an inguinal hernia repair, components of the perfix light plug became loose and detached.The physical sample has been received for evaluation.Preliminary visual inspection of the sample finds the inner petals are detached from the outer shell and the monofilament that holds the petals together is not present.Further review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.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
As reported, during an inguinal hernia repair on (b)(6) 2025, using a perfix light plug while "securing the mesh with threads, the joint (overlapped part) of the plug mesh came loose." it was reported that the mesh was not trimmed or reshaped before use.Another mesh was used, and the surgery was completed without any problems.There was no patient harm or injury.
Additional Manufacturer Narrative
As reported, during an inguinal hernia repair, components of the perfix light plug became loose and detached.The physical sample has been received for evaluation.Preliminary visual inspection of the sample finds the inner petals are detached from the outer shell and the monofilament that holds the petals together is not present.Further review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Evaluation of the returned sample confirmed the reported issue: the inner petals were detached from the outer shell.However, the discrepancy could not be attributed to a manufacturing-related cause, and therefore, a definitive root cause could not be determined.A review of manufacturing records confirmed that the product was manufactured according to specifications, with no anomalies noted that could contribute to this condition.To date, this is the only reported complaint from the manufacturing lot of 513 units released for distribution.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
As reported, during an inguinal hernia repair on (b)(6) 2025, using a perfix light plug while "securing the mesh with threads, the joint (overlapped part) of the plug mesh came loose." it was reported that the mesh was not trimmed or reshaped before use.Another mesh was used, and the surgery was completed without any problems.There was no patient harm or injury.

• 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: 23315674
• Report Number: 1213643-2025-00995
• Device Sequence Number: 12212914
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963(17)291028(10)HUJY0463
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0117070
• Device Lot Number: HUJY0463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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: Other
• Patient Sex: Unknown