MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-06-16 for MIST THERAPY SYSTEM CP-80004 * manufactured by Celleration, Inc..
[20768133]
Employee at hospital had experienced an incident wher her fingertip touched the tip of the transducer. The incident was reported during a site visit on 4/24/2006 to our sales representative. The employee was trying to adjust the applicator while the system was turned on, which is contrary to the instructions for use. The employee experienced a burn on their finger that was no longer visible at the time of the report. Employee acknowledged that she should have paused the system prior to trying to re-seat the applicator.
Patient Sequence No: 1, Text Type: D, B5
[20826348]
Delay in filing this report due to it being the first filed by the manufacturer in device history.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004580659-2006-00002 |
| MDR Report Key | 726835 |
| Report Source | 05 |
| Date Received | 2006-06-16 |
| Date of Report | 2006-06-12 |
| Date of Event | 2006-04-24 |
| Date Mfgr Received | 2006-04-24 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2006-06-20 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | KATHY SIMPSON, QUALITY CONSULTA |
| Manufacturer Street | 10250 VALLEY VIEW RD STE 137 |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 9522248700 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIST THERAPY SYSTEM |
| Generic Name | * |
| Product Code | NRB |
| Date Received | 2006-06-16 |
| Returned To Mfg | 2006-05-02 |
| Model Number | CP-80004 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 715249 |
| Manufacturer | CELLERATION, INC. |
| Manufacturer Address | * EDEN PRAIRIE MN * US |
| Baseline Brand Name | MIST THERAPY SYSTEM |
| Baseline Generic Name | * |
| Baseline Model No | CP-80004 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-06-16 |