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

Catalog Number	0112750
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Micturition Urgency (1871); Pain (1994); Numbness (2415)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As per ansm report ((b)(4)): as reported, on (b)(6) 2021 the patient underwent right inguinal hernia repair with the implant of perfix plug.Description of the incident: pain since an operation for a right-sided inguinal hernia on (b)(6) 2021, slightly lessened since a further operation on (b)(6) 2023 (resection of a nodule opposite the scar from the first operation): sensation of numbness around the scar, external and internal pain (spermatic canal, right testicle, viscera), frequent and urgent urge to urinate, with the last drop taking a while to come out afterwards.No pain or symptoms described in this area prior to the operation, not even between the time the hernia appeared and the operation.Current condition: these pains are hindering the rehabilitation.I am undergoing following back and joint problems (present for 15 years), a burnout in (b)(6) 2023, partly linked to these pains; the operation on (b)(6) 2023 did not improve the situation.On sick leave since then; mdph case pending.Actions taken by the healthcare facility to manage the patient: none.
Additional Manufacturer Narrative
As reported, post implant of a perfix plug the patient had pain (spermatic canal, right testicle, viscera), sensation of numbness around the scar, frequent urge to urinate and had surgical intervention.Based on the information provided, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative symptoms.The adverse reaction section of the instructions-for-use, supplied with the device identifies pain as a possible complication.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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
• 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: 24968682
• Report Number: 1213643-2026-00554
• Device Sequence Number: 4991907
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592(17)250928(10)HUEW1689
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

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: 09/28/2025
• Device Catalogue Number: 0112750
• Device Lot Number: HUEW1689
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2020
• 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