MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-09-21 for MIST THERAPY SYSTEM CP-80004 manufactured by Celleration, Inc..
[715740]
The treatment nurse was having issues with getting the applicator to work while administering treatment with the mist therapy system. She did not deactivate the system when removing the applicator tip. The nurse pulled off the applicator to re-seat it on the transducer. Her middle left finger brushed the transducer tip and she received a slight friction burn. The treatment nurse then proceeded to use the mist therapy system to treat the burn. The burn dud not produce a blister on the finger, nor was there any further injury to the finger. The burn has not presented any long-term problem for the treatment nurse.
Patient Sequence No: 1, Text Type: D, B5
[7863402]
The mist therapy system involved in the reported event is manufactured in 06/2006. The facility has two units, and it was unclear as to which was involved in the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004580659-2007-00003 |
| MDR Report Key | 917366 |
| Report Source | 07 |
| Date Received | 2007-09-21 |
| Date of Report | 2007-09-20 |
| Date of Event | 2007-08-26 |
| Date Mfgr Received | 2007-08-26 |
| Date Added to Maude | 2007-11-13 |
| 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 | 2007-09-21 |
| Catalog Number | CP-80004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 900690 |
| Manufacturer | CELLERATION, INC. |
| Manufacturer Address | EDEN PRAIRIE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-09-21 |