MAUDE Adverse Event Report: LIFESTYLES; LATEX CONDOM

Device Problem Cross Reactivity (1137)

Patient Problem Reaction (2414)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

On 06/09/2016 lot number information not provided, unable to identifiy which manufacturing location provided the subject device.

Event Description

Customer called in saying she was on the to the emergency room because she used a flavored condom and she got a bad allergic reaction.

• Brand Name: LIFESTYLES
• Type of Device: LATEX CONDOM
• MDR Report Key: 5708489
• MDR Text Key: 46868036
• Report Number: 1019632-2016-00005
• 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: Patient
• Type of Report: Initial
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 06/09/2016
• Distributor Facility Aware Date: 06/07/2016
• Device Age: 1 YR
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 18 YR
• Patient Weight: 57