MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-07-10 for HYDRATION STATION manufactured by Sybaritic, Inc..
[2872884]
Victim inadvertently raised her leg while unit was in operation, causing her knee to come in contact with ir emitter on the hood of the unit. Victim claims that she sustained a burn to her knee and sought medical attention, however, victim has not been forthcoming with medical records or other info necessary to complete full investigation.
Patient Sequence No: 1, Text Type: D, B5
[10020362]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2135127-2009-00003 |
| MDR Report Key | 2651239 |
| Report Source | 06 |
| Date Received | 2009-07-10 |
| Date of Report | 2009-07-07 |
| Date of Event | 2009-06-06 |
| Date Facility Aware | 2009-06-06 |
| Report Date | 2009-07-07 |
| Date Reported to FDA | 2009-07-07 |
| Date Mfgr Received | 2009-07-07 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2012-07-13 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | VARBOLA, MARJAMMA VALD |
| Manufacturer City | RAPLAMMA 78203 |
| Manufacturer Country | EN |
| Manufacturer Postal | 78203 |
| Manufacturer Phone | 372489880 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRATION STATION |
| Generic Name | DERMALIFE SPA CAPSULE |
| Product Code | GFE |
| Date Received | 2009-07-10 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Age | 3 YR |
| 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 | 2009-07-10 |