MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-09-26 for MICROBIOLOGY BRUSH 1650 * manufactured by Boston Scientific.
[216919]
Wire to handle bent, broke when removed from package.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022944 |
| MDR Report Key | 353573 |
| Date Received | 2001-09-26 |
| Date of Report | 2001-09-14 |
| Date of Event | 2001-09-07 |
| Date Added to Maude | 2001-10-01 |
| 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 | MICROBIOLOGY BRUSH |
| Generic Name | STERILE SPECIMEN BRUSH |
| Product Code | GEE |
| Date Received | 2001-09-26 |
| Model Number | 1650 |
| Catalog Number | * |
| Lot Number | 3805164 |
| ID Number | * |
| Device Expiration Date | 2003-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 342793 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 480 PLEASANT ST WATERTOWN MA 02472 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-09-26 |