MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-23 for ORAL SALIVA EJECTORS-NON REMOVABLE TIP 0002-SEW manufactured by Atlanta Dental Aupply.
[1336673]
During endoscopic procedure, tip of oral suction catheter fell off while being used to suction patient. Tip lodged in hypopharynx requiring retrieval. Immediately upon discovery of missing tip, endoscopy performed to retrieve tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015276 |
| MDR Report Key | 1639140 |
| Date Received | 2010-03-23 |
| Date of Report | 2010-03-22 |
| Date of Event | 2010-03-19 |
| Date Added to Maude | 2010-03-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORAL SALIVA EJECTORS-NON REMOVABLE TIP |
| Generic Name | ORAL SALIVA / ORAL SUCTION CATHETER |
| Product Code | DYN |
| Date Received | 2010-03-23 |
| Model Number | 0002-SEW |
| Catalog Number | 0002-SEW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATLANTA DENTAL AUPPLY |
| Manufacturer Address | 1650 SATELITE BLVD DULUTH GA 30097 US 30097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-23 |