MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-09 for OMNIBATCH 10 BW * manufactured by X-rite.
[139118]
Exposed to chemical fumes emitted from equipment that malfunctioned in the darkroom in the radiology dept. Symptoms included fatigue and headache. Equipment was removed from hosp, odor dissipated, a sulfur gas was emitted. Air tested for h2s. Results negative employee became a pt seen in er. Treated & released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 304190 |
| MDR Report Key | 304190 |
| Date Received | 2000-11-09 |
| Date of Report | 2000-11-08 |
| Date of Event | 2000-10-30 |
| Date Facility Aware | 2000-10-30 |
| Report Date | 2000-11-08 |
| Date Reported to FDA | 2000-11-08 |
| Date Reported to Mfgr | 2000-11-08 |
| Date Added to Maude | 2000-11-15 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIBATCH 10 BW |
| Generic Name | SAFETY KLEEN SILVER RECOVERY UNIT |
| Product Code | IXW |
| Date Received | 2000-11-09 |
| Returned To Mfg | 2000-10-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 294374 |
| Manufacturer | X-RITE |
| Manufacturer Address | 44TH ST. S.W. GRANDVILLE MI 494182567 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-11-09 |