MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-11-17 for MEDI-AIRE BIOLOGICAL ODOR ELIMINATOR, 1 OZ 7000 L manufactured by C.r. Bard, Inc..
[14351]
40-yr-old female developed respiratory distress from biological odor spray. She went into respiratory distress with syncopal episode after another employee had sprayed the odor eliminator to eliminate odor on intensive care unit. Required solumedrol 100%, non-rebreather mask with o2 at 15 lpm and nebulizer treatment. Was able to go home that evening approx 2 hrs after event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007707 |
| MDR Report Key | 28154 |
| Date Received | 1995-11-17 |
| Date of Report | 1995-11-07 |
| Date of Event | 1995-10-18 |
| Date Added to Maude | 1995-11-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDI-AIRE BIOLOGICAL ODOR ELIMINATOR, 1 OZ |
| Generic Name | ODOR ELIMINATOR |
| Product Code | FRF |
| Date Received | 1995-11-17 |
| Catalog Number | 7000 L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29077 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | MURRAY HILL NJ 07974 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-11-17 |