MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-02-22 for GRACEY 9/10 CUR #6 HNDLE 70-738 manufactured by Integra York, Pa Inc..
[3387867]
Tip broke off, pt almost swallowed due to gag reflex (b)(6) 2013. Doctor was scaling and planing teeth when this occurred, no harm to pt.
Patient Sequence No: 1, Text Type: D, B5
[10557280]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2013-00010 |
| MDR Report Key | 2999109 |
| Report Source | 06 |
| Date Received | 2013-02-22 |
| Date of Report | 2013-02-22 |
| Date Mfgr Received | 2013-02-02 |
| Date Added to Maude | 2013-05-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer Country | US |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRACEY 9/10 CUR #6 HNDLE |
| Generic Name | M52 - HYGIENE / PERIODONTAL |
| Product Code | DZP |
| Date Received | 2013-02-22 |
| Catalog Number | 70-738 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-22 |