MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-02-04 for MIST THERAPY SYSTEM CP-80004 manufactured by Celleration, Inc..
[1043742]
Treatment nurse was sitting on the floor treating a pt with a foot injury. The device transducer wand was in her right hand and she placed her left hand in front of the transducer to check for a mist. She claims that she did not touch the tip, but felt a shock and the pain traveled up her arm. After treatment, she removed her glove and the injury caused a blister. She notice that the glove had 2 pin holes in it. The injury caused pain to the area for a day but is healing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004580659-2009-00001 |
| MDR Report Key | 1321295 |
| Report Source | 07 |
| Date Received | 2009-02-04 |
| Date of Report | 2009-02-03 |
| Date of Event | 2009-01-05 |
| Date Mfgr Received | 2009-01-05 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2010-01-07 |
| 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 | 2009-02-04 |
| Returned To Mfg | 2009-01-28 |
| 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 | 2009-02-04 |