MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-22 for MIST THERAPY SYSTEM CP-80004 manufactured by Celleration, Inc..
[1666338]
Treatment nurse was treating a pt and said she touched the tip of the transducer with the palm of her gloved right hand because she didn't think she was seeing enough saline mist coming off of the transducer. She received an acoustic burn, and immediately removed her hand. No damage to her glove or skin. She said she realized right away that she wasn't supposed to touch it while it was on. Besides the initial sensation on her hand, she did not have any long lasting pain or any damage as a result of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004580659-2010-00001 |
| MDR Report Key | 1881701 |
| Report Source | 05 |
| Date Received | 2010-10-22 |
| Date of Report | 2010-10-15 |
| Date of Event | 2010-09-30 |
| Date Mfgr Received | 2010-09-30 |
| Date Added to Maude | 2012-03-15 |
| 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 | SUSAN GEBHARD, COORD. |
| 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 | 2010-10-22 |
| 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 | 2010-10-22 |