MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-15 for STAND UP TANNING BOOTH manufactured by Unk.
[75420043]
Name of person injured: (b)(6). Type of injury: fainted/hit nose. Duration of tanning exposure: 12 minutes power tower. Treatment: gave her water and cold towel. Blood drawn and x-ray. Client fainted in the tanning room, when she regained conscious she immediately left the salon without speaking to employee working and sat in her car until her friend showed up. Her friend then came in and told me what happened and i got her water and a towel. Her friend drove her to emergency room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069827 |
| MDR Report Key | 6572378 |
| Date Received | 2017-05-15 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-04-25 |
| Date Added to Maude | 2017-05-17 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STAND UP TANNING BOOTH |
| Generic Name | "BOOTH SUN TAN" |
| Product Code | LEJ |
| Date Received | 2017-05-15 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-15 |