MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-22 for O2 SENSOR manufactured by .
[41252192]
He was misdiagnosed with copd. Combivent,ipratropium bromide, put in the hospital, had allergic reaction. Also o2 sensor caused him not to get enough oxygen to lungs and heart, they're killing him. It's all a fraud. Dose or amt: 2x, frequency: twice daily, route: inhalation. Diagnosis or reason for use: supposedly copd. Event abated after use stopped or dose reduced: no. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061253 |
| MDR Report Key | 5525726 |
| Date Received | 2016-03-22 |
| Date of Report | 2016-03-22 |
| Date of Event | 2016-03-22 |
| Date Added to Maude | 2016-03-25 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | O2 SENSOR |
| Generic Name | O2 SENSOR |
| Product Code | CCL |
| Date Received | 2016-03-22 |
| Lot Number | 502762A |
| ID Number | 7133103 |
| Device Expiration Date | 2016-03-18 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2016-03-22 |