MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-14 for HUGGIES SIMPLY CLEAN BABY WIPES manufactured by Kimberly Clark.
[19689716]
I used huggies brand simply clean baby wipes to remove makeup on a saturday night when i awoke sunday morning, my eyelids and edges of my lips were burned and swollen. The product did not burn as i was removing the make up. I have used baby wipes of all kinds for this use and never had an adverse reaction. This was the first time i used the simply clean kind. I discontinued use. To date, i still have redness and now scaling in the eye and lip areas. I did report this to kimberly clarke and sent them a sample. Thank you. You may give my contact info to the mfg, as i have already done that.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026963 |
| MDR Report Key | 2751786 |
| Date Received | 2012-09-14 |
| Date of Report | 2012-09-14 |
| Date of Event | 2012-08-18 |
| Date Added to Maude | 2012-09-24 |
| 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 |
| 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 SIMPLY CLEAN BABY WIPES |
| Generic Name | BABY WIPES |
| Product Code | LDQ |
| Date Received | 2012-09-14 |
| Returned To Mfg | 2012-09-12 |
| Lot Number | UNK |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY CLARK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-09-14 |