MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-12-30 for MIST THERAPY SYSTEM CP-80004 manufactured by Celleration, Inc..
[1022098]
Wound care nurse stated she had "burned her hand" on the transducer wand. She stated there was no break in the skin, but this had happened before to the tech as well. The nurse reported the event to the employee health nurse at the facility. The nursing staff using the device have been retrained and reminded that the burn is a friction burn and not heat related.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004580659-2008-00005 |
| MDR Report Key | 1278311 |
| Report Source | 07 |
| Date Received | 2008-12-30 |
| Date of Report | 2008-12-30 |
| Date of Event | 2008-12-02 |
| Date Mfgr Received | 2008-12-02 |
| Date Added to Maude | 2009-12-04 |
| 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 | 0 |
| Manufacturer Contact | KATHY SIMPSON, CONSULTANT |
| Manufacturer Street | 10250 VALLEY VIEW ROAD SUITE 137 |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 9522248700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIST THERAPY SYSTEM |
| Generic Name | NONE |
| Product Code | NRB |
| Date Received | 2008-12-30 |
| Model Number | CP-80004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELLERATION, INC. |
| Manufacturer Address | EDEN PRAIRIE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-12-30 |