MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-15 for SEVENTH GENERATION FREE AND CLEAR BABY WIPES manufactured by Rockline Industries.
[3819663]
This report is being filed voluntarily under the fda guidance for industry cosmetics, good manufacturing practices manual. A consumer used seventh generation baby wipes to clean up her child after the child had vomited on herself in her car seat. Within 24 hours of using the wipes, the child developed a rash. The consumer took her daughter to the hospital and was told it was an allergic reaction. The consumer reported that the child was prescribed "something for the itch".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1648563-2013-00001 |
| MDR Report Key | 3338805 |
| Date Received | 2013-08-15 |
| Date of Report | 2013-08-14 |
| Date of Event | 2013-08-03 |
| Date Facility Aware | 2013-08-07 |
| Report Date | 2013-08-14 |
| Date Added to Maude | 2013-09-12 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Manufacturer Street | 60 LAKE ST. |
| Manufacturer City | BURLINGTON VT 05401 |
| Manufacturer Country | US |
| Manufacturer Postal | 05401 |
| Manufacturer G1 | SEVENTH GENERATION |
| Manufacturer Street | 60 LAKE ST. |
| Manufacturer City | BURLINGTON VT 05401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 05401 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEVENTH GENERATION FREE AND CLEAR BABY WIPES |
| Generic Name | BABY WIPES |
| Product Code | LDQ |
| Date Received | 2013-08-15 |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCKLINE INDUSTRIES |
| Manufacturer Address | 1300 ROCKLINE WAY SPRINGDALE AR 72764 US 72764 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-15 |