MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-06-03 for HYDRATION STATION manufactured by Sybaritic, Inc..
[2872027]
User accidentally hit the top of his hand on the ir emitter while moving arm to adjust temperature of the unit. User sought medical attention and physician diagnosis of injury was a 2nd degree burn.
Patient Sequence No: 1, Text Type: D, B5
[10093628]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2135127-2009-00002 |
| MDR Report Key | 2651328 |
| Report Source | 06 |
| Date Received | 2009-06-03 |
| Date of Report | 2009-06-01 |
| Date of Event | 2009-09-20 |
| Date Facility Aware | 2009-05-20 |
| Report Date | 2009-06-01 |
| Date Reported to FDA | 2009-06-01 |
| Date Mfgr Received | 2009-05-20 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2012-07-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Street | VARBOLA MARJAMMA VALD |
| Manufacturer City | RAPLAMME 78203 |
| Manufacturer Country | EN |
| Manufacturer Postal | 78203 |
| Manufacturer Phone | 3724898800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRATION STATION |
| Generic Name | DERMALIFE CAPSULE |
| Product Code | IMB |
| Date Received | 2009-06-03 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYBARITIC, INC. |
| Manufacturer Address | BLOOMINGTON MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-03 |