MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-06-07 for MIST THERAPY SYSTEM CP-80004 manufactured by Celleration, Inc..
[669068]
Pt developed a rash around the wound being treated by mist therapy. The rash was in the area where the saline was applied by the mist. The family of the pt told the nursing home that the pt has had the same reaction to sodium chloride before. It was unk to celleration whether this allergy was documented by the site as a pre-existing condition. The pt's rash subsided after discontinuing use of the saline mist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004580659-2007-00002 |
| MDR Report Key | 863140 |
| Report Source | 00 |
| Date Received | 2007-06-07 |
| Date of Report | 2007-06-07 |
| Date of Event | 2007-05-14 |
| Date Mfgr Received | 2007-05-14 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2008-02-28 |
| 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 |
| 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 | UNK |
| Product Code | NRB |
| Date Received | 2007-06-07 |
| Catalog Number | CP-80004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 957978 |
| Manufacturer | CELLERATION, INC. |
| Manufacturer Address | EDEN PRAIRIE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-07 |