MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-04-21 for MIST THERAPY SYSTEM CP-80004 manufactured by Celleration, Inc..
[15445998]
Treatment nurse stated she received a shock from the transducer wand during a patient treatment. Nurse described the shock as "an intense sensation" when she touched the transducer tip, and felt the sensation only at the point of the injury.
Patient Sequence No: 1, Text Type: D, B5
[15658153]
Company representative reviewed proper use of the device and adherence to the ifu with individual involved in this report as follow-up to the incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004580659-2009-00002 |
| MDR Report Key | 1369278 |
| Report Source | 05 |
| Date Received | 2009-04-21 |
| Date of Report | 2009-04-20 |
| Date of Event | 2009-03-06 |
| Date Mfgr Received | 2009-03-06 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2010-03-03 |
| 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 | 2009-04-21 |
| 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 | 2009-04-21 |