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

Catalog Number	0112960
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	01/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2004 - patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of perfix plug (device #1).Per op notes, ¿a large indirect hernia sac was identified and reduced.A small cord lipoma was noted and excised.A large perfix plug (device #1) was placed with onlay patch using prolene sutures.¿ (b)(6) 2010 - patient was diagnosed with recurrent right inguinal hernia with pain and left inguinal hernia thereby underwent open repair with implant of perfix plug (device #2 & #3).Per op notes, ¿on right inguinal region the prior mesh (device #1) was adherent to external oblique was taken down and opened.An indirect hernia defect was identified and reduced.A perfix plug (device #2) was placed and sutured.The previous mesh (device #1) was intact and sewed back again with sutures.On the left inguinal region an indirect sac was identified and reduced.A perfix plug (device #3) was placed and sutured.¿ (b)(6) 2010 ¿ patient had a right lower quadrant and groin pain.(b)(6) 2019 ¿ patient had a chronic right groin pain.(b)(6) 2020 ¿ it was alleged that the patient had right groin pain and moderate infection suggested with pain medications.(b)(6) 2020 ¿ it was alleged that patient had second revision surgery to fix the torn and out of place hernia mesh.
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-mar-2010) is considered to be a best estimate.This mdr 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.

• 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: 22676280
• Report Number: 1213643-2025-00702
• Device Sequence Number: 18376933
• Product Code: FTL
• UDI-Device Identifier: 00801741016660
• UDI-Public: (01)00801741016660(17)250328(10)HUUC0059
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2025

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: 03/28/2025
• Device Catalogue Number: 0112960
• Device Lot Number: HUUC0059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2010
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 111 KG