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

Catalog Number	0112970
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Hernia (2240)
Date of Event	06/21/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Addendum per additional information provided: (b)(6) 2010 - patient was diagnosed with incarcerated left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1).Per operative notes, ¿once all the sac has been pulled up and reduced, the cord is clearly identified.A large plug is placed into the defect and sutured.¿ (b)(6) 2010 - patient presents with pain.(b)(6) 2010 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with removal of perfix plug (device #1) and implant of perfix plug (device #2).Per operative notes, ¿the mesh was palpable and it was dissected free from area which is inferior to the mesh.The mesh was removed with sharp and blunt dissection.Then, a large perfix plug (device #2) was selected and placed into the resulting defect using sutures." (b)(6) 2011 - patient complains of incisional pain and presents with left groin hernia recurrence which contain bulge that goes down towards the pubic tubercle and a little beyond.(b)(6) 2011 - patient was diagnosed with symptomatic recurrent left inguinal hernia thereby underwent laparoscopic repair with the implant of synthetic mesh.Per operative notes, ¿there was no evidence of direct and femoral hernias.A very large and long indirect hernia was identified and the hernia sac was completely reduced and dissected the edge of peritoneum.A piece of synthetic mesh was then tailored, inserted into peritoneal cavity, secured to cooper¿s ligament using tacks." (there was no visualization of perfix plug (device #2)).(b)(6) 2012 - patient was diagnosed with left groin wound infection thereby underwent open repair with removal of infected prolene mesh.Per operative notes, ¿the mesh was deformed and appeared to be consistent with prolene mesh, sutured to the external oblique aponeurosis or inguinal ligament inferiorly and superiorly as well.The mesh was completely dissected free and purulence was found around the mesh." attorney alleges that the patient had pain, hernia recurrence, infection and emotional injuries.
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 6 months post implant of perfix plug, patient was diagnosed with hernia recurrence, scar tissue and pain.The adverse reaction section of the instructions-for-use, supplied with the device identify hernia recurrence as a possible complication.Review of manufacturing records confirms product was manufactured to specification.This emdr 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.; 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 ; 4018258495
• MDR Report Key: 20254974
• Report Number: 1213643-2024-094697
• Device Sequence Number: 18078123
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677(17)110528(10)43EQD743
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/19/2024

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: 05/28/2011
• Device Catalogue Number: 0112970
• Device Lot Number: 43EQD743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2006
• 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: 30 YR
• Patient Sex: Male
• Patient Weight: 97 KG