MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for RUSCH IPN048387 004551004 manufactured by Teleflex Medical.
[184081949]
A middle-aged female with history of elevated blood pressure and svt. Undergoing procedure ankle/foot arthrodesis/fusion and bone graft. Anesthesia assessment identified a loose #9 tooth and warned the patient of risk. During intubation, the crna advanced the laryngoscope and it snapped in half, causing the front tooth of the patient to loosen/dislocate from gum. In pacu, the tooth came out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9852939 |
| MDR Report Key | 9852939 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-03-10 |
| Report Date | 2020-03-10 |
| Date Reported to FDA | 2020-03-10 |
| Date Reported to Mfgr | 2020-03-19 |
| Date Added to Maude | 2020-03-19 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH |
| Generic Name | LARYNGOSCOPE, RIGID |
| Product Code | CCW |
| Date Received | 2020-03-19 |
| Model Number | IPN048387 |
| Catalog Number | 004551004 |
| Lot Number | 1907341 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |