MAUDE Adverse Event Report: LIFESTYLES; NATURAL RUBBER LATEX CONDOM

Model Number NOT PROVIDED

Device Problem Insufficient Information (3190)

Patient Problem Local Reaction (2035)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

At this time, insufficient information has been provided by the initial reporter to identify which of the two manufacturing facilities the device could have come from.(b)(4).

Event Description

Contact advised that he and girlfriend used a lifestyle condom (no specific product name, lot code, or product identifier information provided).Afterwards, there were complications that resulting in spending 8 hours in a emergency room at a hospital.No other information provided.

• Brand Name: LIFESTYLES
• Type of Device: NATURAL RUBBER LATEX CONDOM
• MDR Report Key: 5490245
• MDR Text Key: 40023798
• Report Number: 1019632-2016-00001
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: NOT PROVIDED
• Device Lot Number: NOT PROVIDED
• 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: 03/09/2016
• Distributor Facility Aware Date: 02/17/2016
• Device Age: 1 YR
• 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: 25 YR