MAUDE Adverse Event Report: LIFESTYLES HEALTHCARE PTE. LTD LIFESTYLES CONDOMS; CONDOM, SYNTHETIC

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
I got on annovera which is a silicone birth control ring.I didn't know that it was not compatible with most condoms.I even reached out to lifestyles condoms and they said all of their condoms are pre-lubricated with silicone oil.This silicone oil can make annovera less effective and so for my safety i had it removed.Now i had to go through trying to get a refund of almost (b)(6) for the ring.It took forever trying to get the ring and i also called annovera to tell them that this ring is not compatible with most condoms.I let them know today though about lifestyles reaching back out to me and saying that all of their condoms come lubricated with silicone lube.

• Brand Name: LIFESTYLES CONDOMS
• Common Device Name: CONDOM, SYNTHETIC
• Manufacturer (Section D): LIFESTYLES HEALTHCARE PTE. LTD; 30 cecil street; #19-08 prudential tower; singapore 04971 2
• MDR Report Key: 21058240
• Report Number: MW5164164
• Device Sequence Number: 18358150
• Product Code: MOL
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Hispanic