MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-22 for BURKHART LABEL SALIVA EJECTOR manufactured by Burkhart Dental Supply.
[6195636]
Tip from (b)(6) private label saliva ejector (product #(b)(4)) was separated while suctioning the patient during a dental procedure. Patient aspirated the tip. He was sent to hospital for a bronchoscopy to remove the tip from his lung.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5044821 |
| MDR Report Key | 4946020 |
| Date Received | 2015-07-22 |
| Date of Report | 2015-07-22 |
| Date of Event | 2015-06-29 |
| Date Added to Maude | 2015-07-29 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BURKHART LABEL SALIVA EJECTOR |
| Generic Name | SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2015-07-22 |
| Returned To Mfg | 2015-07-15 |
| Lot Number | 04-10-151 |
| ID Number | 72720635 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BURKHART DENTAL SUPPLY |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2015-07-22 |