MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-17 for MINIATURE PIN & LIGATURE CUTTER ODG1002 manufactured by Gac International.
[2194909]
In this event it was reported that the tip of a miniature pin and ligature cutter separated outside of a pt's mouth; there is no indication that injury resulted.
Patient Sequence No: 1, Text Type: D, B5
[9346720]
The device was returned for eval and was found to have exceeded the expected life of the device. While no serious injury resulted in this event, there has been a previous report rec'd in past two yrs 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2086211-2011-00005 |
| MDR Report Key | 2264973 |
| Report Source | 05 |
| Date Received | 2011-08-17 |
| Date of Report | 2011-07-18 |
| Date Mfgr Received | 2011-07-18 |
| Date Added to Maude | 2012-06-21 |
| 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. PHILADELPHIA ST, STE 60 SUSQUEHANNA COMMERCE CTR 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 | MINIATURE PIN & LIGATURE CUTTER |
| Product Code | EJB |
| Date Received | 2011-08-17 |
| Returned To Mfg | 2011-08-11 |
| Catalog Number | ODG1002 |
| Lot Number | 03-43 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAC INTERNATIONAL |
| Manufacturer Address | BOHEMIA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-17 |