MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-20 for MICROSHIELD UNKNOWN manufactured by Armstrong Medical Industries, Inc..
[10822]
A nurse was doing cpr to a person bleeding from the mouth using device. The one-way valve failed and the nurse got a mouth full of blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002893 |
| MDR Report Key | 14783 |
| Date Received | 1994-07-20 |
| Date of Report | 1994-07-19 |
| Date of Event | 1994-07-14 |
| Date Added to Maude | 1994-07-21 |
| 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 |
| 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 | MICROSHIELD |
| Generic Name | CPR CLEAR MOUTH BARRIER |
| Product Code | BYP |
| Date Received | 1994-07-20 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 14777 |
| Manufacturer | ARMSTRONG MEDICAL INDUSTRIES, INC. |
| Manufacturer Address | LINCOLNSHIRE IL 60069 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-07-20 |