MAUDE Adverse Event Report: LIFESTYLES; LATEX CONDOM

LIFESTYLES; LATEX CONDOM

Medical Device Problem Code	Cross Reactivity (1137)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	09/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016 consumer upon using the product got a severe reaction and had to go to the emergency room because genital area had swelling.No other information provided at the time of the event.

Search Alerts/Recalls

1 Device was Involved in the Event
Brand Name	LIFESTYLES
Common Device Name	LATEX CONDOM
MDR Report Key	5943598
Report Number	1019632-2016-00008
Device Sequence Number	10127739
Product Code	HIS
Combination Product (Y/N)	N
Initial Reporter State	NJ
Initial Reporter Country	US
Number of Events Summarized	1
Summary Report (Y/N)	N
Reporter Type	Importer
Initial Reporter Occupation	Other
Type of Report	Initial
Report Date (Section B)	09/12/2016
Report Date (Section F)	09/12/2016
1 Patient was Involved in the Event
Is this an Adverse Event Report?	Yes
Operator of Device	No Information
Was Device Available for Evaluation?	No
Was the Report Sent to FDA?	Yes
Distributor Facility Aware Date	09/06/2016
Event Location	Home
Type of Report(Section G)	Thirty-Day
Initial Date Received by Manufacturer	Not provided
Initial Report FDA Received Date	09/12/2016
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N)	No
Patient Sequence Number	1
Outcome Attributed to Adverse Event	Hospitalization;
Patient Age	18 YR
Date Report Sent to FDA	09/12/2016