MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-17 for ASPIRATORY DENTAL manufactured by Kent Dental.
[15930]
During procedure the tip of the oral aspirator was noted to be missing. Could not be located above cords. Pt developed cough and wheezing. Required bronchoscopy for tip removal. Invalid data - regarding single use labeling of device. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 22137 |
| MDR Report Key | 22137 |
| Date Received | 1995-04-17 |
| Date of Report | 1995-04-14 |
| Date of Event | 1995-04-13 |
| Date Facility Aware | 1995-04-13 |
| Report Date | 1995-04-14 |
| Date Reported to FDA | 1995-04-14 |
| Date Reported to Mfgr | 1995-04-13 |
| Date Added to Maude | 1995-05-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPIRATORY DENTAL |
| Generic Name | ORAL ASPIRATOR |
| Product Code | EHZ |
| Date Received | 1995-04-17 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 22234 |
| Manufacturer | KENT DENTAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-04-17 |