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

Catalog Number	0112750
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	04/30/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 6 years 8 months post implant of perfix plug, patient was diagnosed with hernia recurrence thereby underwent repair.The instructions-for-use supplied with the device list hernia recurrence as possible complication.This emdr represents the bard/davol perfix plug (device #1).An additional supplemental emdr was submitted to represent the bard/davol perfix plug (device #2).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 left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1).Per operative notes, ¿the defect at the base of the inguinal floor was identified and a perfix plug (device #1) placed and secured using sutures, then a patch was placed over the top of the plug and tacked.¿ (b)(6) 2012 - patient was diagnosed with symptomatic direct right inguinal hernia thereby underwent open repair with the implant of perfix plug (device #2).Per operative notes, ¿the hernia sac was dissected and a perfix plug (device #2) placed in the inguinal floor and sutured.Then, a precut patch was secured over the top of the plug using sutures.¿ (b)(6) 2014 - patient was diagnosed with recurrent left inguinal hernia and right lower quadrant incisional hernia thereby underwent open repair with the implant of perfix plug (device #3 & device #4) and explant of perfix plug (device #2).Per operative notes, ¿the direct hernia in the medial portion of the left inguinal floor was found and a perfix plug (device #3) was placed and secured using sutures.In the right lower quadrant, hernia was identified after removing perfix plug (device #2) and a perfix plug (device #4) inserted into the hole and sutured.¿ (note: there was no mention/visualization of the previously placed perfix plug (device #1) during this procedure.) attorney alleged that the patient had mesh migration, mesh shrinkage, pain, hernia recurrence and emotional injuries.

• 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: 20876078
• Report Number: 1213643-2024-094846
• Device Sequence Number: 15664436
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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 Catalogue Number: 0112750
• Device Lot Number: 43HQD062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 94 KG