MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-02-05 for MILTEX SELF ASPIRATING SYRINGE 76-100 manufactured by Miltex Instrument Co..
[19898782]
After doctor injected pt with a mandibular bloc, he removed syringe from pt's mouth, went to remove the needle from the syringe, found needle not present in the syringe, looked immediately in pt's mouth, found needle with "hub" attached, removed it successfully without incident. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2431021-1997-90002 |
| MDR Report Key | 104338 |
| Report Source | 05 |
| Date Received | 1997-02-05 |
| Date of Report | 1997-01-15 |
| Date Added to Maude | 1997-07-11 |
| 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 | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILTEX |
| Generic Name | SELF ASPIRATING SYRINGE |
| Product Code | EJI |
| Date Received | 1997-02-05 |
| Model Number | SELF ASPIRATING SYRINGE |
| Catalog Number | 76-100 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 102653 |
| Manufacturer | MILTEX INSTRUMENT CO. |
| Manufacturer Address | 6 OHIO DR. LAKE SUCCESS NY 11042 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-02-05 |