MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-07-17 for MIST THERAPY SYSTEM CP-8004 * manufactured by Celleration, Inc..
[480542]
Physician therapist (pt) treating a wound was accidentally sprayed in the face. Pt experienced bloodshot eyes and a splotchy face following the event. At the time of the event, the pt had her face as close to the surface of the wound as possible without any protective equipment (such as a mask or goggles) in order to ensure that the tip of the device's plastic applicator did not come in contact with the surface of the pt's wound. The pt has a history of multiple allergies. The mfr's instructions for use state that the user of the device sould follow appropriate infection control procedures while administering treatment.
Patient Sequence No: 1, Text Type: D, B5
[7848931]
Add'l info received from pt on 7/14/2006: pt continued to have red and itchy eyes over the next week due to allergic reactions from three different antibiotic eye drops she was given from occupational health, e. R. , and her allergist. Her allergist felt as though the reactions she was experiencing were due to one of the components of the antibiotic drops, and unrelated to the incident in this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004580659-2006-00004 |
| MDR Report Key | 736785 |
| Report Source | 00 |
| Date Received | 2006-07-17 |
| Date of Event | 2006-06-21 |
| Date Mfgr Received | 2006-06-22 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2006-07-20 |
| 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 |
| 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 | 2006-07-17 |
| Model Number | CP-8004 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 724673 |
| Manufacturer | CELLERATION, INC. |
| Manufacturer Address | * EDEN PRAIRIE MN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-07-17 |