MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-18 for HUGGIES BABY WIPES manufactured by Kimberly-clark.
[3112485]
Rash, fissures, allergic reaction to ingredient methylisothiazolinone - present in both products: huggies baby wipes and bumble and bumble shine shampoo by estee lauder. Dates of use: (b)(6) 2011 - (b)(6) 2012. Event abated after use stopped: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026802 |
| MDR Report Key | 2732677 |
| Date Received | 2012-07-18 |
| Date of Report | 2012-07-18 |
| Date of Event | 2011-03-01 |
| Date Added to Maude | 2012-09-10 |
| 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 | 3 |
| 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 | HUGGIES BABY WIPES |
| Generic Name | BABY WIPES |
| Product Code | LDQ |
| Date Received | 2012-07-18 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-18 |