MAUDE Adverse Event Report: LIFESTYLES; LATEX CONDOM

Device Problem Cross Reactivity (1137)

Patient Problem Reaction (2414)

Event Date 09/06/2016

Event Type  Injury  

Event 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.

• Brand Name: LIFESTYLES
• Type of Device: LATEX CONDOM
• MDR Report Key: 5943598
• MDR Text Key: 54500517
• Report Number: 1019632-2016-00008
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2016
• Distributor Facility Aware Date: 09/06/2016
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 18 YR