MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-08-15 for GRACEY 9/10 CUR #6 HNDLE 70-738 manufactured by Integra York, Pa Inc.
[3609158]
Customer initially reports the tip broke off, pt almost swallowed. On (b)(6) 2013 customer reported the hygienist was doing routine scaling and root planing (cleaning) with no particular force when the tip broke off. Pt was not harmed.
Patient Sequence No: 1, Text Type: D, B5
[11073457]
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 | 2523190-2013-00052 |
| MDR Report Key | 3300947 |
| Report Source | 06 |
| Date Received | 2013-08-15 |
| Date of Report | 2013-08-15 |
| Date Mfgr Received | 2013-08-08 |
| Date Added to Maude | 2013-11-12 |
| 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 DR |
| 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 | EAX |
| Date Received | 2013-08-15 |
| Catalog Number | 70-738 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-08-15 |