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 Codes	Purulent Discharge (1812); Unspecified Infection (1930); Obstruction/Occlusion (2422)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2010 ¿ patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of prefix plug (device #1, #2).Per operative notes, ¿a medium sized direct was noted.A large and extra-large prefix plug (device #1, #2) were sewn together to one larger plug and placed to direct space and onlay patch was placed along the floor of groin and secured to pubic tubercle, cooper¿s ligament and inguinal ligament using sutures.¿ on (b)(6) 2017 ¿ patient had acute diverticulitis with abscess and adhesion with closed loop obstruction thereby underwent small bowel resection.Per operative notes, ¿there were multiple loops of small bowel densely adherent to the pelvic floor was dissected free.There was frank purulent discharge on opening the abscess cavity and loop of bowel were resected.¿ on (b)(6) 2018 ¿ patient was diagnosed with infection and left inguinal pain thereby underwent open repair with removal of mesh (device #1, #2).Per operative notes, ¿there was a swelling where a large mesh plug (device #1, #2) was noted.Dense adhesions in the subcutaneous tissues and fascia were divided.The infected mesh was divided towards the peritoneum and a large amount of thick purulent and foul-smelling drainage was obtained.The mesh (device #1, #2) was dissected off the femoral artery and removed.¿ on (b)(6) 2019 ¿ patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of synthetic 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-jul-2009) is considered to be a best estimate.This emdr was submitted to represent the bard/davol perfix plug (device #2).An additional supplemental emdr submitted to represent the bard/davol 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: 22505400
• Report Number: 1213643-2025-00632
• Device Sequence Number: 20995675
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615(17)140830(10)HUTG1838
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: 08/30/2014
• Device Catalogue Number: 0112770
• Device Lot Number: HUTG1838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2009
• 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: Male