MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-01-20 for XPZC 13-14 CURETTE XPZC13-14 manufactured by American Eagle Instruments, Inc..
[20016939]
I was not able to interview the customer/end-user who was working with the product when they experienced the event. I had very limited info available to me. A 4+ year old dental hand instrument (specifically a curette with a life expectancy of 6-12 months) was being used on a patient's mouth (unsure of the exact procedure being performed) when the point of the instrument (the working portion) came out of the insert (a component of the handle portion of the instrument which joins the point to the handle) and lodged in the patients throat. The loose point was removed resulting in 'minor' injury to the patient. There was no indication of what action or activity took place or was taking place to cause the point to come out of the insert.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000127001-2014-00001 |
| MDR Report Key | 4456932 |
| Report Source | 06,07 |
| Date Received | 2015-01-20 |
| Date of Report | 2015-01-16 |
| Date of Event | 2014-11-30 |
| Date Mfgr Received | 2014-11-18 |
| Device Manufacturer Date | 2010-09-02 |
| Date Added to Maude | 2015-01-28 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. BRAD DAVIS |
| Manufacturer Street | 6575 BUTLER CREEK RD. |
| Manufacturer City | MISSOULA MT 59808 |
| Manufacturer Country | US |
| Manufacturer Postal | 59808 |
| Manufacturer Phone | 4065327310 |
| Manufacturer G1 | AMERICAN EAGLE INSTRUMENTS, INC. |
| Manufacturer Street | 6575 BUTLER CREEK RD. |
| Manufacturer City | MISSOULA MT 59808 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 59808 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPZC 13-14 CURETTE |
| Generic Name | UNIVERSAL CURETTE |
| Product Code | EKT |
| Date Received | 2015-01-20 |
| Model Number | XPZC13-14 |
| Catalog Number | XPZC13-14 |
| Lot Number | 0IB |
| Device Expiration Date | 2011-03-30 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN EAGLE INSTRUMENTS, INC. |
| Manufacturer Address | 6575 BUTLER CREEK RD. MISSOULA MT 59808 US 59808 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-20 |