MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-27 for DRAVON UNK manufactured by Dravon.
[92254]
Following a donor rbcp procedure while blood samples were being collected, air was noticed to be in the tubing. Disposable hemostats had been applied. Pt complained of ache in chest area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 118698 |
| MDR Report Key | 118698 |
| Date Received | 1997-06-27 |
| Date of Report | 1997-05-28 |
| Date of Event | 1997-04-24 |
| Date Facility Aware | 1997-04-24 |
| Report Date | 1997-05-28 |
| Date Added to Maude | 1997-09-12 |
| 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 | DRAVON |
| Generic Name | DISPOSABLE PLASTIC HEMOSTAR |
| Product Code | HRQ |
| Date Received | 1997-06-27 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 116389 |
| Manufacturer | DRAVON |
| Manufacturer Address | 11465 SOUTHEAST HWY 212 CLACKAMAS OR 97015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-06-27 |