MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-07-15 for DISTAL END CUTTER BIG JOHN 1016U manufactured by Gac International.
[1367035]
It was reported that the tip of a distal end cutter separated in a patient's mouth; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
[8610626]
While no serious injury resulted in this event, there has been a previous report received in the past two years involving a similar device where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2086211-2010-00101 |
| MDR Report Key | 1765968 |
| Report Source | 05 |
| Date Received | 2010-07-15 |
| Date of Report | 2010-06-16 |
| Date of Event | 2010-06-10 |
| Date Mfgr Received | 2010-06-16 |
| Date Added to Maude | 2011-02-11 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILA. ST., STE. 60 SUSQUEHANNA COMMERCE CENTER W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | ORTHODENTAL INTL., INC. |
| Manufacturer Street | 2306 M.L. KING SUITE 1 |
| Manufacturer City | CALEXICO CA 92231 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92231 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISTAL END CUTTER |
| Product Code | EJB |
| Date Received | 2010-07-15 |
| Catalog Number | BIG JOHN 1016U |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAC INTERNATIONAL |
| Manufacturer Address | BOHEMIA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 16 | 2010-07-15 |