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

Catalog Number	0112780
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2019- patient was diagnosed with recurrent left inguinal hernia, right inguinal hernia, thereby underwent robotic assisted laparoscopic repair with implant of perfix plugs (device 1 and 3), 3dmax light meshes (device 2 and 4).Per op notes, "on the left inguinal region, an indirect hernia sac was identified and was dissected.In the right inguinal region, hernia sac was identified and dissected.A perfix plug (device 1) was placed over the internal ring and was sutured.A 3dmax light mesh (device 2) was placed aswell as superiorly and laterally using sutures.On the left inguinal region, perfix plug (device 3) was placed and sutured and the 3dmax light mesh (device 4) was placed and secured medially, superiorly and laterally using sutures." (b)(6) 2019 - patient was diagnosed with recurrent right inguinal hernia, pain, thereby underwent open repair with implant of synthetic mesh.Per op notes, "in the right inguinal region, hernia with palpable mesh was identified.An incarcerated indirect hernia sac was identified on the lateral surface of the cord and the hernia sac was dissected.A synthetic mesh was placed and sutured.".
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-oct-2018) is considered to be a best estimate.This emdr represents the bard perfix plug (device 1).Additional supplemental emdrs were submitted to represent the 3dmax light mesh (device 2 & 4).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: 25552000
• Report Number: 1213643-2026-00774
• Device Sequence Number: 5547646
• Product Code: FTL
• UDI-Device Identifier: 00801741016622
• UDI-Public: (01)00801741016622(17)231028(10)HUCX1038
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: 10/28/2023
• Device Catalogue Number: 0112780
• Device Lot Number: HUCX1038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2018
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 118 KG