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

Catalog Number 0112970

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Discomfort (2330); Dysuria (2684)

Event Date 11/30/2016

Event Type  malfunction  

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 reported postoperative pain/discomfort.No medical intervention has been required.At this time there is no identified malfunction of the device.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of 582 units.Should additional information be provided, a supplemental emdr will be submitted.Remains implanted.

Event Description

It was reported that the patient underwent a laparoscopic inguinal hernia repair on (b)(6) 2016 and was implanted with a bard/davol perfix plug.As reported that pain and discomfort began within three (3) weeks of the mesh being implanted and prior to the patients follow-up appointment.As reported, the patient went to his follow-up appointment where he discussed the pain with his surgeon stating "the pain is only when i am lifting heavy objects and at the tip of his penis after urinating but not every time." as reported the surgeon explained that, he may experience some pain and discomfort after surgery and that he should not be lifting any heavy objects.As reported, the patient has not used any pain medication or had any other consultations with his surgeon about the pain and has just occasionally used a heating pad and ice packs when he is experiencing pain in the area of the incision.

• 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: 8859093
• MDR Text Key: 153255205
• Report Number: 1213643-2019-06653
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 0112970
• Device Lot Number: HUAU0197
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2016
• 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