MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-15 for RSV 2011/01 * manufactured by Binax, Inc..
[21377817]
R. N. Inserted rsv influenza swab into nostril of infant. Tip of applicator noted missing after removing from infant nostril. Defective. Noted tip inside packaging. Patient exhibited small amount of bleeding from right nostril.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 824135 |
| MDR Report Key | 824135 |
| Date Received | 2007-02-15 |
| Date of Report | 2007-02-14 |
| Date of Event | 2007-02-08 |
| Report Date | 2007-02-14 |
| Date Reported to FDA | 2007-02-15 |
| Date Added to Maude | 2007-03-08 |
| 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 | 3 |
| 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 | RSV |
| Generic Name | KIT, INFLUENZA TEST |
| Product Code | GRP |
| Date Received | 2007-02-15 |
| Model Number | 2011/01 |
| Catalog Number | * |
| Lot Number | 8995 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 811537 |
| Manufacturer | BINAX, INC. |
| Manufacturer Address | 10 SOUTHGATE RD. SCARBOROUGH ME 04074 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-15 |