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

Catalog Number 0112770

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Disability (2371); Ambulation Difficulties (2544)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any, the implanted device may have caused or contributed to the post implant clinical course reported by the patient.As reported imaging did not reveal a device malfunction or recurrence of the hernia.In addition, explant procedure details have not been provided.At this time no conclusion can be made.The warning section of the instructions-for-use state, "to avoid injury, careful attention is required if fixating the mesh in the presence of nerves or vessels." a review of the manufacturing records was performed and found that the lot was manufactured to specification should additional information be provided, a supplemental emdr will be submitted.The information provided by bard 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 bard.Not returned.

Event Description

The following was reported, via maude event report (mw5078318): "reporter alleges she experienced severe muscle spasm in her legs a day after being implanted with perfix plug mesh for hernia repair.Reporter advised she was pain free when in bed.However, activities of daily living became hard to accomplish as sitting, standing, walking and general ambulation came with excruciating pain.Lastly, she alleges numbness of lower extremities and continues to experience it even after device explant." the following was reported during follow up with the contact.On (b)(6) 2018 the patient underwent the repair of a right inguinal hernia and was implanted with a davol perfix plug.As reported following the repair the patient experienced pain which became severe.The patient advised the nursing staff of her pain but did not see the surgeon until her follow up visit at which time she was ambulating with a cane due to the severity of the pain.The surgeon ordered imaging studies which the patient reports did not reveal any malfunction of the device or recurrence of the hernia.The patient reports due to the severity of the pain, the surgeon performed an additional surgery on 02/07/2018 to explant the device and repair the hernia without mesh.The patient reports she continues to have occasional numbness and burning sensation in her leg but is able to walk and sit without difficulty after the explant of the mesh.This was a primary hernia with no previous surgeries in the location of the right groin.

• Brand Name: PERFIX PLUG
• Type of Device: 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7762540
• MDR Text Key: 116414655
• Report Number: 1213643-2018-02673
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615
• 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: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2022
• Device Catalogue Number: 0112770
• Device Lot Number: HUBS0615
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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; Disability