MAUDE Adverse Event Report: THE FEMALE HEALTH CO. REALITY CONDOMS; SINGLE-USE INTERNAL CONDOM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2009

Event Type  Injury  

Event Description

Had to go periodic vaginal screenings had 2 previously tubal ligations.Implanted on (b)(6) 1993, explanted on (b)(6) 2009.

• Brand Name: REALITY CONDOMS
• Type of Device: SINGLE-USE INTERNAL CONDOM
• Manufacturer (Section D): THE FEMALE HEALTH CO.
• MDR Report Key: 12058706
• MDR Text Key: 258452499
• Report Number: MW5102111
• Device Sequence Number: 1
• Product Code: MBU
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2019
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR