MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-23 for NATURACARE ORGANIC AND NATURAL PANTYLINERS BOX OF 30 COUNT CURVED 1414246 manufactured by Natracare.
[5752798]
(b)(4). I used naturacare pantyliner for 3 days and developed an allergic skin reaction with severe acute blisters where the pantyliner adhesive touched my skin. I went to dermatologist for help and diagnosis and confirmed it was an allergic reaction. I am allergic to methylisothiazolinone and it must be in the adhesive at a high enough concentration to elicit a reaction. The blisters are not going away. Mfr: natracare llc, body wise ((b)(4)) ltd made in (b)(4). Retailer: (b)(6). Explanation: they are not answering adhesive ingredients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041666 |
| MDR Report Key | 4643321 |
| Date Received | 2015-03-23 |
| Date of Report | 2015-03-12 |
| Date of Event | 2015-03-09 |
| Date Added to Maude | 2015-04-01 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATURACARE ORGANIC AND NATURAL PANTYLINERS BOX OF 30 COUNT CURVED |
| Generic Name | PERSONAL PROTECTION |
| Product Code | HHD |
| Date Received | 2015-03-23 |
| Model Number | 1414246 |
| ID Number | 141246 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATRACARE |
| Manufacturer Address | GREELEY CO 80634185 US 80634 1852 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-23 |