MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-25 for CRESCENT RINN A DIVISION OF DENTSPLY PRODUCT #C200030 * manufactured by Crescent Rinn A Div Of Dentsply International, Inc..
[17108538]
Rubber cup pops off from the plastic shaft if the pt even bites lightly on this attachment causing either a choking or aspiration risk. There was no injury to pt, but reporter is concerned that a high risk is possible if the cap comes off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031339 |
| MDR Report Key | 514804 |
| Date Received | 2004-02-25 |
| Date Added to Maude | 2004-03-10 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRESCENT RINN A DIVISION OF DENTSPLY |
| Generic Name | R.A. WEBBED CUPS |
| Product Code | EHK |
| Date Received | 2004-02-25 |
| Model Number | PRODUCT #C200030 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 503811 |
| Manufacturer | CRESCENT RINN A DIV OF DENTSPLY INTERNATIONAL, INC. |
| Manufacturer Address | 1212 ABBOTT DRIVE ELGIN IL 601231819 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-02-25 |