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	Adhesion(s) (1695)
Date of Event	08/18/2017
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 emdr was submitted to represent the ventrio hernia patch (device #1).Note, the manufacturing date (15-feb-2013) 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
Per information provided: on (b)(6) 2011 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventrio hernia patch (device #1).Per op notes, ¿a ventrio hernia patch (device #1) was tacked up to the anterior abdominal wall with staples.¿ on (b)(6) 2014 - patient was diagnosed with right femoral hernia with obstruction and ischemic bowel thereby underwent open repair with the implant of perfix plug (device #2).Per op notes, ¿a perfix plug & patch (device #2) was placed to the inguinal ligament using prolene sutures.¿ on (b)(6) 2017 - patient was diagnosed with right colon cancer and a large right groin incisional hernia thereby underwent removal of mesh (device #1 & #2).Per op notes, ¿adhesions to the previous mesh were dissected off the mesh.The mesh (device #1 & #2) was completely excised on both sides of the abdominal wall.¿ on (b)(6) 2017 - patient was diagnosed with incarcerated incisional hernia, recurrent right groin thereby underwent open repair with the implant of perfix plug (device #3).Per op notes, ¿an extra-large plug (device #3) was placed and sutured with prolene sutures.¿.

• 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: 22345792
• Report Number: 1213643-2025-00539
• Device Sequence Number: 15581690
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615(17)180228(10)HUXB1027
• 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: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2025

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 Expiration Date: 02/28/2018
• Device Catalogue Number: 0112770
• Device Lot Number: HUXB1027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2013
• 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: 75 YR
• Patient Sex: Female