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: SURETEX LTD. LIFESTYLES SKYN; LUBRICATED POLYISOPRENE CONDOM
  • 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
 

SURETEX LTD. LIFESTYLES SKYN; LUBRICATED POLYISOPRENE CONDOM Back to Search Results
Catalog Number 7312
Device Problem Material Rupture (1546)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
The customer informed ansell healthcare products, llc that the lifestyles polyisoprene lubricated condom she was using broke and she was now being tested for std.
 
Manufacturer Narrative
(b)(4).Ansell healthcare products llc is submitting this report on behalf of (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIFESTYLES SKYN
Type of Device
LUBRICATED POLYISOPRENE CONDOM
Manufacturer (Section D)
SURETEX LTD.
bangalore AL
IN 
Manufacturer Contact
tammy mcgriff
1635 industrial rd.
dothan, AL 36303
3346152566
MDR Report Key3628645
MDR Text Key3984853
Report Number1019632-2014-00003
Device Sequence Number1
Product Code MOL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/01/2015
Device Catalogue Number7312
Device Lot Number1205100222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/30/2014
Distributor Facility Aware Date01/28/2014
Device Age3 YR
Event Location Other
Date Report to Manufacturer01/30/2014
Date Manufacturer Received01/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
-
-