MAUDE Adverse Event Report: LIFESTYLES NATURAL RUBBER LATEX CONDOMS

Model Number UNKNOWN

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Injury (2348)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

On 10/11/2017 - no device identifier information provided from user.Awaiting input in order to continue investigation.

Event Description

On 10/11/2017 customer indicated that there was a foreign object in the condom which caused a cut to the penis.No doctor intervention indicated.

• Brand Name: LIFESTYLES NATURAL RUBBER LATEX CONDOMS
• Type of Device: NATURAL RUBBER LATEX CONDOM
• MDR Report Key: 6940382
• MDR Text Key: 89157600
• Report Number: 1019632-2017-00013
• 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: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 10/11/2017
• Distributor Facility Aware Date: 09/27/2017
• 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): Required Intervention
• Patient Age: 20 YR