MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-07 for MINITROL DENTAL CART 2644 manufactured by A-dec Inc..
[16271254]
The water supply bottle exploded during a procedure. Several staff members experienced temporary hearing difficulties as a result of the noise. The pt will require audiology testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 28380 |
| MDR Report Key | 28380 |
| Date Received | 1995-07-07 |
| Date of Report | 1995-07-06 |
| Date Added to Maude | 1995-12-05 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINITROL DENTAL CART |
| Generic Name | DENTAL CART |
| Product Code | ECB |
| Date Received | 1995-07-07 |
| Model Number | 2644 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29308 |
| Manufacturer | A-DEC INC. |
| Manufacturer Address | PO BOX 111 NEWBERG OR 971320111 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-07-07 |