MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-06-06 for QUICK TIP BARNHART 5 AECB5XPQT manufactured by American Eagle Instruments, Inc..
[670527]
Adverse event - dental instrument broke off during procedure. Pt was healthy prior to incident. Pt required additional treatment/surgery after incident. Approx two days later, the surgical area became infected causing the pt a lot of pain and additional care.
Patient Sequence No: 1, Text Type: D, B5
[7962241]
Microscopic visual performed for process defamation or metallurgical anomalies - no anomalies observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3027615-2007-00001 |
| MDR Report Key | 862669 |
| Report Source | 08 |
| Date Received | 2007-06-06 |
| Date of Report | 2007-05-08 |
| Date of Event | 2007-04-11 |
| Date Mfgr Received | 2007-05-08 |
| Device Manufacturer Date | 2006-08-30 |
| Date Added to Maude | 2007-06-13 |
| 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 | ANDIE BARTOLET |
| Manufacturer Street | 6575 BUTLER CREEK RD. |
| Manufacturer City | MISSOULA MT 59808 |
| Manufacturer Country | US |
| Manufacturer Postal | 59808 |
| Manufacturer Phone | 4065497451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICK TIP |
| Generic Name | EMS: VARIOUS SIZES AND STYLES OF PERIODONTIC INSTRUMENTS |
| Product Code | EMS |
| Date Received | 2007-06-06 |
| Model Number | BARNHART 5 |
| Catalog Number | AECB5XPQT |
| Lot Number | HV6 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 846363 |
| Manufacturer | AMERICAN EAGLE INSTRUMENTS, INC. |
| Manufacturer Address | 6575 BUTLER CREEK RD. MISSOULA MT 59808 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-06 |