Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD BENLUX SILICONE FOLEY CATHETER
  • 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
 

PRODUCTOS PARA EL CUIDADO DE LA SALUD BENLUX SILICONE FOLEY CATHETER Back to Search Results
Catalog Number 165812
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that a cuff roll was noted on the balloon upon catheter removal.Balloon was inflated w/10cc sterile water and indwelling time was unknown.
 
Manufacturer Narrative
Investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BENLUX SILICONE FOLEY CATHETER
Manufacturer (Section D)
PRODUCTOS PARA EL CUIDADO DE LA SALUD
nogales, sonora
MX 
Manufacturer (Section G)
PRODUCTOS PARA EL CUIDADO DE LA SALUD
km. 7 carretera internacional
nogales, sonora 8562 1
MX   85621
Manufacturer Contact
kim shirah
8195 industrial blvd.
covington, GA 30014
7707846100
MDR Report Key3736478
MDR Text Key21312771
Report Number1018233-2014-00025
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 01/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number165812
Device Lot NumberNGXHY321
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/21/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-