MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-15 for MIST THERAPY SYSTEM CP-80004 manufactured by Celleration, Inc..
[15184052]
Nurse called to report operational issue with mist therapy system, and that she had touched the end of the transducer to see if the horn was broken. She stated the transducer was hot, burned through her glove, and burned her finger, resulting in a blister. Several attempts to contact the reporter for add'l info about the reported event have been unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[15653272]
Mfr's eval of system involved in reported event revealed system operating within temperature specifications. An attempt was made to duplicate the report of the horn being hot enough to burn through a glove, however, the mfr was unable to do so, as the horn tip does not reach a temperature sufficient to burn through a latex glove when the ultrasound is off.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004580659-2008-00002 |
| MDR Report Key | 1031761 |
| Report Source | 05 |
| Date Received | 2008-04-15 |
| Date of Report | 2008-04-15 |
| Date of Event | 2008-03-28 |
| Date Mfgr Received | 2008-03-28 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2009-10-28 |
| 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 | 2008-04-15 |
| Returned To Mfg | 2008-04-08 |
| Model Number | CP-80004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2008-04-15 |