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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOT PROVIDED AT TIME OF REPORT LIFESTYLES; NATURAL RUBBER LATEX CONDOM
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NOT PROVIDED AT TIME OF REPORT LIFESTYLES; NATURAL RUBBER LATEX CONDOM Back to Search Results
Model Number NOT PROVIDED AT TIME OF REPORT
Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)
Patient Problem Unspecified Infection (1930)
Event Date 07/27/2017
Event Type  Injury  
Manufacturer Narrative
On 07/28/2017 - as of this date, no information available to specific product subject to the complaint and thus no lot code or manufacturer identity can be established.
 
Event Description
On (b)(6) 2017 customer contacted that they used a lifestyles natural rubber latex condom and they contracted a sti.
 
Manufacturer Narrative
(b)(6) 2017 - as of this date, no information available to specific product subject to the complaint and thus no lot code or manufacturer identity can be established.(b)(6) 2017 - ansell was contacted by the customer that a false report was submitted on his behalf without his knowledge.No sti was contracted.No further investigation.
 
Event Description
(b)(6) 2017 customer contacted that they used a lifestyles natural rubber latex condom and they contracted a sti.(b)(6) 2017 customer indicated a false report was made on his behalf.No such sti was contracted.
 
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Brand Name
LIFESTYLES
Type of Device
NATURAL RUBBER LATEX CONDOM
Manufacturer (Section D)
NOT PROVIDED AT TIME OF REPORT
MDR Report Key6750650
MDR Text Key81314243
Report Number1019632-2017-00011
Device Sequence Number1
Product Code HIS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/28/2017,09/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberNOT PROVIDED AT TIME OF REPORT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/28/2017
Distributor Facility Aware Date07/27/2017
Event Location Home
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age20 YR
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