MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-07-17 for MIST THERAPY SYSTEM CP-80004 manufactured by Celleration, Inc..
[18110965]
Treatment nurse stated that the friction burn to his finger occurred when he was attempting to deal with the transducer button on the mist therapy system. The button was not functioning properly and required repeated "presses" to keep the ultrasound going to complete the patient's treatment. The nurse stated he was not paying close attention to where his free hand was, he touched the tip of the transducer and received the friction burn. Celleration customer service reviewed instructions for use with the nurse, and he was unaware that the transducer was not to be touched while on. Proper procedure was reviewed with the nurse, and sales rep will be following up with any additional training that may be required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004580659-2008-00003 |
| MDR Report Key | 1079502 |
| Report Source | 05 |
| Date Received | 2008-07-17 |
| Date of Report | 2008-07-17 |
| Date of Event | 2008-07-01 |
| Date Mfgr Received | 2008-07-09 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2009-09-10 |
| 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 |
| 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 | 2008-07-17 |
| Model Number | CP-80004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2008-07-17 |