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

Catalog Number 0112750

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Hernia (2240)

Event Date 04/01/2015

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, no conclusions can be made.As reported, patient experienced pain and hernia recurrence about 7 years post-implant of the perfix plug.Based on the information obtained, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions for use supplied with the device as a possible complication.Note, the date of event is considered to be a best estimate as (b)(6) 2015 based on the information provided.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.Not returned - remains implanted.

Event Description

As reported, the patient underwent an inguinal hernia repair surgery on (b)(6) 2015 with implant of a bard/davol perfix plug and had been experiencing ongoing pain for a long time.As reported, the patient underwent an ultrasound, which noted a wall defect and hernia recurrence.

Event Description

As reported, the patient underwent an inguinal hernia repair surgery on (b)(6) 2015 with implant of a bard/davol perfix plug and had been experiencing ongoing pain for a long time.As reported, the patient underwent an ultrasound, which noted a wall defect and hernia recurrence.

Manufacturer Narrative

Based on the information provided, no conclusions can be made.As reported, patient experienced pain and hernia recurrence about 7 years post-implant of the perfix plug.Based on the information obtained, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions for use supplied with the device as a possible complication.Note, the date of event is considered to be a best estimate as 01-apr-2015 based on the information provided.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the corrected expiry date and dhr review results.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) released for distribution in january, 2015.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
• Type of Device: 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: 15178340
• MDR Text Key: 297409997
• Report Number: 1213643-2022-00571
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Catalogue Number: 0112750
• Device Lot Number: HUYK1404
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male