MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-07-26 for SALIVA EJECTOR 100-4092 manufactured by Asa Dental.
[454383]
The tip of the saliva ejector came off and was swallowed by the pt during a bronchoscopy procedure. They began to wake the pt up when they noticed that the tip was missing. They then stopped waking up the pt and reintroduced the bronchoscope. The tip of the saliva ejector had entered the pt's lung, but the doctor was able to retrieve it by using a snare. The bronchoscope was then removed and the pt was awakened. No complications were reported. The pt is doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2005-14203 |
| MDR Report Key | 719920 |
| Date Received | 2005-07-26 |
| Date of Report | 2005-07-25 |
| Date of Event | 2005-06-27 |
| Date Facility Aware | 2005-06-27 |
| Report Date | 2005-07-25 |
| Date Reported to FDA | 2005-07-25 |
| Date Reported to Mfgr | 2005-07-25 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2006-05-31 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SALIVA EJECTOR |
| Generic Name | DENTAL SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2005-07-26 |
| Model Number | NA |
| Catalog Number | 100-4092 |
| Lot Number | C310 MAY O5 008800 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 708988 |
| Manufacturer | ASA DENTAL |
| Manufacturer Address | VIA VALENZANA 60 BOZZANO LU, IT 55050 |
| Baseline Brand Name | SALIVA EJECTOR |
| Baseline Generic Name | DENTAL SALIVA EJECTOR |
| Baseline Model No | NA |
| Baseline Catalog No | 100-4092 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-07-26 |