MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-09 for POMEROY EAR SYRINGE UNK manufactured by Unk.
[200898]
Pt was seen in the clinic for ear wax build up. The nurse was irrigating the pt's right ear with an ear syringe, when the syringe came apart. The tip went into the ear causing some bleeding, however the pt did move at the time the device came apart. A physician examined the pt after the incident and noted the area of bleeding, which appeared to have stopped. The pt denied any tenderness, but some erythema of the external auditory canal was noted. The pt was discharged in satisfactory condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 305183 |
| MDR Report Key | 305183 |
| Date Received | 2000-11-09 |
| Date of Report | 2000-11-09 |
| Date of Event | 2000-10-20 |
| Date Facility Aware | 2000-10-30 |
| Report Date | 2000-11-09 |
| Date Reported to FDA | 2000-11-09 |
| Date Added to Maude | 2000-11-21 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POMEROY EAR SYRINGE |
| Generic Name | EAR IRRIGATION SYRINGE |
| Product Code | KCP |
| Date Received | 2000-11-09 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 295353 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-11-09 |