MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-25 for LIGEJECT 76-50 manufactured by Miltex Instrument Co..
[50455]
Miltex instrument co, inc. 6 ohio drive, cb 5006, lake success, ny 11042-0006. We have concluded that this incident is not a direct result of the device's failure but rather improper use and maintenance and, as such, no remedial action is planned at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007442 |
| MDR Report Key | 27462 |
| Date Received | 1995-10-25 |
| Date of Report | 1995-10-11 |
| Date of Event | 1994-12-22 |
| Date Added to Maude | 1995-10-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGEJECT |
| Generic Name | DENTAL INTERLIGAMENTARY SYRINGE |
| Product Code | EGM |
| Date Received | 1995-10-25 |
| Model Number | 76-50 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 28359 |
| Manufacturer | MILTEX INSTRUMENT CO. |
| Manufacturer Address | LAKE SUCCESS NY 110420006 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-10-25 |