MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-23 for PATTERSON DENTAL CO. 005428 089-4097 manufactured by *.
[16828145]
The distal end of the saliva ejector (dental tip) suction catheter broke off during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037282 |
| MDR Report Key | 654907 |
| Date Received | 2005-11-23 |
| Date of Report | 2005-11-14 |
| Date of Event | 2005-09-06 |
| Date Added to Maude | 2005-12-22 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | PATTERSON DENTAL CO. |
| Generic Name | SALIVA EJECTOR DENTAL TIP SUCTION CATHETER |
| Product Code | DYN |
| Date Received | 2005-11-23 |
| Model Number | 005428 |
| Catalog Number | 089-4097 |
| Lot Number | NONE |
| ID Number | VENDOR 005428 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 644389 |
| Manufacturer | * |
| Manufacturer Address | 600 RESEARCH DR WILMINGTON MA 01887 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-11-23 |