• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DAVOL INC., SUB. C.R. BARD, INC. PERFIX PLUG; SURGICAL MESH Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8859093
MDR Text Key153255205
Report Number1213643-2019-06653
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741016677
UDI-Public(01)00801741016677
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K922916
Number of Events Reported1
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 Date07/28/2021
Device Catalogue Number0112970
Device Lot NumberHUAU0197
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/09/2019
Initial Date FDA Received08/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-