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 Code	Pain (1994)
Date of Event	03/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of the perfix plug, the patient experienced pain at upper arms, and difficulty lifting heavy objects with arms.The patient's surgeon does not feel the patient's reported symptoms are related to the mesh.Imaging and surgeon's evaluation of the implant site show a normally healing hernia, no recurrent hernia and no fluid or lesions at the site of the hernia repair.The repair site is healing normally.It is unclear what is causing the patient's upper body symptoms; however, it does not appear to be related to the implant used to treat the patient's inguinal hernia.Review of manufacturing records confirms product was manufactured to specification.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Note, the date of event (15-mar-2025) is considered to be a best estimate.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, the patient was implanted with perfix plug during an indirect inguinal hernia on (b)(6) 2025.It was reported two weeks post op she had suffered limited function in her upper arms, pain, and difficulty lifting heavy objects with arms.Per surgeon there are no symptoms or pain at the surgical site in the groin where the mesh was implanted, and surgical site area was healing normally.The patient followed up with the surgeon again two months post op who states the patient still reports upper body pain and weakness, and joint issues.However, there is no fluid or lesions or recurrent hernia at the site of the hernia repair.The patient's surgeon reports he does not feel the patient's reported symptoms are related to the mesh, but the patient believes the issues are linked to the hernia repair.

• 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: 22100507
• Report Number: 1213643-2025-00416
• Device Sequence Number: 7390217
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592(17)280628(10)HUHU0789
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

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 Catalogue Number: 0112750
• Device Lot Number: HUHU0789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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: Female