MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-08 for BUSSE HOSPITAL DISPOSABLES 2966 manufactured by Busse Hospital Disposables.
| Report Number | 2433012-2019-00001 |
| MDR Report Key | 9165605 |
| Date Received | 2019-10-08 |
| Date of Report | 2019-09-30 |
| Date of Event | 2019-07-01 |
| Report Date | 2019-08-01 |
| Date Reported to FDA | 2019-08-01 |
| Date Reported to Mfgr | 2019-09-19 |
| Date Mfgr Received | 2019-09-24 |
| Device Manufacturer Date | 2019-03-18 |
| Date Added to Maude | 2019-10-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS ANGELA WALDRON |
| Manufacturer Street | 1400 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8476899101 |
| Manufacturer G1 | BUSSE HOSPITAL DISPOSABLES |
| Manufacturer Street | 75 ARKAY DR |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11788 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUSSE HOSPITAL DISPOSABLES |
| Generic Name | BULK PACKED YANKAUER WITHOUT VENT/ OPEN TIP/ NON-STERILE |
| Product Code | GCX |
| Date Received | 2019-10-08 |
| Catalog Number | 2966 |
| Lot Number | 1960164, 1860904 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BUSSE HOSPITAL DISPOSABLES |
| Manufacturer Address | 75 ARKAY DR HAUPPAUGE NY 11788 US 11788 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-08 |