MAUDE Adverse Event Report: ALWAYS; ALWAYS FEMININE PAD

Lot Number 5050478300

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Urticaria (2278)

Event Date 04/16/2015

Event Type  No Answer Provided  

Event Description

Been getting hives from always feminine pads.Just noticed the pattern last month there is something wrong with these pads not just these but something with what they put on it gives me hives in private parts, now it has extended to other areas.Have changed detergent and underwear, it is the pads! from 2014 to last month, notice the pattern as it only occurs with usage of always products, now using organic pads and nothing.Also noticed lots of online comments about it now that i am looking closely at the problem.Dates of use: (b)(6) 2014 - (b)(6) 2015.Diagnosis or reason for use: menstruation pads.Event abated after use stopped or dose reduced: yes.Event reappeared after reintroduced: yes.

• Brand Name: ALWAYS
• Type of Device: ALWAYS FEMININE PAD
• MDR Report Key: 4724224
• MDR Text Key: 5736306
• Report Number: MW5042201
• Device Sequence Number: 1
• Product Code: HHD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 5050478300
• Other Device ID Number: PO904289239
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2015
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 77