MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-15 for V. MUELLER MO 156 manufactured by Carefusion.
[1746707]
Dr placed mcivor mouth gag in pt's mouth. The mayo stand was brought in over pt's chest and mouth gag attached. Mayo stand was elevated to provide traction and expose tonsils. The mcivor mouth gag broke at weld upon elevation and exposure was lost. No injury to pt. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018606 |
| MDR Report Key | 1932673 |
| Date Received | 2010-12-15 |
| Date of Report | 2010-12-14 |
| Date of Event | 2010-12-07 |
| Date Added to Maude | 2010-12-23 |
| 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 | V. MUELLER |
| Generic Name | MCIVOR MOUTH GAG |
| Product Code | KBN |
| Date Received | 2010-12-15 |
| Model Number | MO 156 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1430 WAUKEGAN ROAD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-15 |