MAUDE Adverse Event Report: ALWAYS; PAD, MENSTRUAL

Device Problem Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2018

Event Type  Injury  

Event Description

Brand always product pads i bought from costco, the smell is extremely pungent.May have benzene exceed the tolerance.Dates of use: (b)(6) 2017 - (b)(6) 2018.Diagnosis or reason for use: period.Is the product compounded: yes.Is the product over-the-counter: yes.

• Brand Name: ALWAYS
• Type of Device: PAD, MENSTRUAL
• MDR Report Key: 7553389
• MDR Text Key: 109703638
• Report Number: MW5077534
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): N
• 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: 05/27/2018

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 28 YR
• Patient Weight: 45