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

Catalog Number 0112750

Device Problem Insufficient Information (3190)

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

Event Type  Injury  

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any the perfix plug may have caused or contributed to the patient's reported postoperative difficulties.As reported the patient is continuing to seek the advice of a medical professional to determine how to proceed medically.At this time no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be obtained, 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.Remains implanted.

Event Description

It was reported that on (b)(6) 2015 the patient underwent inguinal repair using the davol perfix plug.After the surgical postoperative appointment the contact reports the pain became worse.The patient was evaluated by multiple md's who performed nerve blocks and other injections which only provided temporary relief.The contact has reported that the patient is unable to find a surgeon who will perform a revision procedure.As reported the patient has been disabled as he has had ambulation difficulty and is unable to drive a vehicle due to his pain.

• 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: 7730803
• MDR Text Key: 115351422
• Report Number: 1213643-2018-02530
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Catalogue Number: 0112750
• Device Lot Number: HUYI1494
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2014
• 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