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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURETEX LTD LIFESTYLES SKYN; LUBRICATED POLYISOPRENE CONDOM
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SURETEX LTD LIFESTYLES SKYN; LUBRICATED POLYISOPRENE CONDOM Back to Search Results
Catalog Number 7312
Device Problem Insufficient Information (3190)
Patient Problem Burning Sensation (2146)
Event Type  Injury  
Event Description
The customer informed ansell healthcare products, llc that after using a lifestyles polyisoprene lubricated condom she suffered severe vaginal burning that required medical attention.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
LIFESTYLES SKYN
Type of Device
LUBRICATED POLYISOPRENE CONDOM
Manufacturer (Section D)
SURETEX LTD
bangalore
IN 
Manufacturer (Section G)
SURETEX LTD.
plot no. 74 to 91
kiadb ind. estate
Manufacturer Contact
1635 industrial rd.
dothan, AL 36303
3346152566
MDR Report Key3940727
MDR Text Key4531640
Report Number1019632-2014-00010
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 06/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/30/2016
Device Catalogue Number7312
Device Lot Number1310100622
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/16/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/16/2014
Distributor Facility Aware Date06/16/2014
Device Age1 YR
Event Location Other
Date Report to Manufacturer06/16/2014
Date Manufacturer Received06/16/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2013
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;
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