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: C.R. BARD, INC. (COVINGTON) -1018233 ULTRAFLEX¿ SELF-ADHERING MALE EXTERNAL CATHETER; MEC
  • 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
 

C.R. BARD, INC. (COVINGTON) -1018233 ULTRAFLEX¿ SELF-ADHERING MALE EXTERNAL CATHETER; MEC Back to Search Results
Catalog Number 33303
Device Problems Shipping Damage or Problem (1570); Device Markings/Labelling Problem (2911)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the control label and country label of the male external catheter did not match.The control label, and the product within the case, were labeled for reference number (b)(4).However, the country label was labeled for reference number (b)(4).
 
Event Description
It was reported that the control label and country label of the male external catheter did not match.The control label, and the product within the case, were labeled for reference number (b)(4).However, the country label was labeled for reference number (b)(4).
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿note: do not use on irritated or compromised skin.Do not use if allergic reaction occurs.If sheath has an insert, remove it.Not made with natural rubber latex.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ULTRAFLEX¿ SELF-ADHERING MALE EXTERNAL CATHETER
Type of Device
MEC
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8190897
MDR Text Key131340962
Report Number1018233-2018-06108
Device Sequence Number1
Product Code NNX
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 01/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number33303
Was Device Available for Evaluation? No
Date Manufacturer Received12/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-