• 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. -1213643 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. -1213643 PERFIX PLUG SURGICAL MESH Back to Search Results
Catalog Number 0112780
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Unspecified Infection (1930); Swelling (2091)
Event Date 09/29/2020
Event Type  Injury  
Manufacturer Narrative
As reported, the patient experienced redness, swelling and pus in the right scrotum post implant of the perfix plug. Based on the information provided to date, no conclusion can be made as to the degree to which the device, may have caused or contributed the patients reported postoperative course. As reported, the patient underwent incision and drainage of pus, treated with antibiotics and recovered. 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 (b)(4) units released for distribution in jan 2019. The instructions-for-use supplied with the device states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " note, the date of event ((b)(6) 2020) is estimated based on the date of implant ((b)(6) 2020) provided. Should additional information be provided, a supplemental mdr will be submitted. Not returned - remains implanted.
 
Event Description
As reported, per the nmpa ((b)(6) health authority), the patient underwent a hernia repair surgery for the implant of a bard/davol perfix plug on (b)(6) 2020 and on the 3rd day post-implant, the patient had redness and swelling of the right scrotum. The patient was treated with anti-infective agents, which were ineffective. Subsequently, the patient underwent incision and drainage of pus, was administered with anti-infective drugs and the patient recovered.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERFIX PLUG
Type of DeviceSURGICAL 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 Key11107833
MDR Text Key224751304
Report Number1213643-2020-20092
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0112780
Device Lot NumberHUCY1479
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/04/2021 Patient Sequence Number: 1
-
-