MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for GREAT WHITE GOLD SERIES METAL CUTTING CAVITY PREPARATION CARBIDE BUR GW-557 18218 manufactured by S.s. White Burs, Inc..
[116073722]
During dental oral rehabilitation procedure, under anesthesia, dentist was using carbide bur for cavity purposes. Distal tip of bur broke off during procedure, and could not be located in patient? S mouth or oropharynx. Pack in place surrounding et tube; anesthesiologist could not locate tip. Patient taken to hospital emergency room for evaluation of retained foreign body. X-rays taken; tip not identified in stomach or lungs. Diagnosis or reason for use: dental cavities. "is the product compounded: no; is the product over-the-counter: yes".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078771 |
| MDR Report Key | 7742365 |
| Date Received | 2018-08-01 |
| Date of Report | 2018-07-30 |
| Date of Event | 2018-06-06 |
| Date Added to Maude | 2018-08-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | GREAT WHITE GOLD SERIES METAL CUTTING CAVITY PREPARATION CARBIDE BUR |
| Generic Name | DENTAL BUR |
| Product Code | EJL |
| Date Received | 2018-08-01 |
| Model Number | GW-557 |
| Catalog Number | 18218 |
| Lot Number | 2017-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | S.S. WHITE BURS, INC. |
| Manufacturer Address | 1145 TOWBIN AVE LAKEWOOD NJ 08701 US 08701 |
| Brand Name | GREAT WHITE GOLD SERIES METAL CUTTING CAVITY PREPARATION CARBIDE BUR |
| Generic Name | DENTAL BUR |
| Product Code | EJL |
| Date Received | 2018-08-01 |
| Model Number | GW-557 |
| Catalog Number | 18218 |
| Lot Number | 2017-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SS WHITE |
| Manufacturer Address | 1145 TOWBIN AVE LAKEWOOD NJ 08701 US 08701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-01 |