MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-16 for ALWAYS * manufactured by *.
[5736306]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042201 |
| MDR Report Key | 4724224 |
| Date Received | 2015-04-16 |
| Date of Report | 2015-04-16 |
| Date of Event | 2015-04-16 |
| Date Added to Maude | 2015-04-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYS |
| Generic Name | ALWAYS FEMININE PAD |
| Product Code | HHD |
| Date Received | 2015-04-16 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 5050478300 |
| ID Number | PO904289239 |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | * |
| Manufacturer Address | * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-16 |