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

Catalog Number	0112770
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
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.This emdr was submitted to represent the bard/davol perfix plug (device #2).An additional supplemental emdrs submitted to represent the bard/davol perfix plug (device #1 & device #3).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
Per information provided: (b)(6) 2007 - patient was diagnosed with bilateral direct and indirect inguinal hernia thereby underwent open repair with the implant of perfix plugs (device #1, #2).Per operative notes, "on both groin, hernia sacs were mobilized and the floor was repaired using perfix plugs (device #1, #2).The patches were also sutured." (b)(6) 2013 - patient was diagnosed with recurrent right inguinal hernia thereby underwent repair with the implant of perfix plug (device #3).Per operative notes, "the previously placed mesh (device #1) was incised, a direct hernia was noted close to the inguinal ring with a lipoma of the cord.This was reduced.A perfix plug (device #3) was placed into the defect and sutured.An onlay patch was secured to the rectus sheath." (b)(6) 2019 - patient was diagnosed with bilateral recurrent inguinal hernia thereby underwent robotic assisted laparoscopic repair with the implant of synthetic meshes.Per operative notes, "the prior mesh plug was noted with hernia sac.Synthetic meshes were placed and tacked.".

• 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: 22410411
• Report Number: 1213643-2025-00578
• Device Sequence Number: 8407339
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615(10)43IQD100
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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: 0112770
• Device Lot Number: 43IQD100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 58 YR
• Patient Sex: Male