MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-19 for EAR IRRIGATION SYRINGE 19-385 * manufactured by Miltex Instrument Co. Inc..
[265023]
Medical assistant cleaning pt's left ear and the ear irrigation syringe came apart and scratched pt's external ear canal. Abrasion minor with slight blood <1cc. Follow up: the medical assistant thought she had assembled the syringe correctly, but apparently must not have done so. Staff checked the syringe out thoroughly. There have been no further incidents and staff is doing a double-check to make sure it is secured properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1027933 |
| MDR Report Key | 449574 |
| Date Received | 2003-03-19 |
| Date of Report | 2003-03-07 |
| Date of Event | 2003-02-05 |
| Date Added to Maude | 2003-03-25 |
| 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 |
| Reporter Occupation | UNKNOWN |
| 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 | EAR IRRIGATION SYRINGE |
| Generic Name | SYRINGE, IRRIGATION |
| Product Code | KCP |
| Date Received | 2003-03-19 |
| Model Number | 19-385 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 438566 |
| Manufacturer | MILTEX INSTRUMENT CO. INC. |
| Manufacturer Address | 700 HICKSVILLE RD BETHPAGE NY 117143496 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-03-19 |