MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-19 for EAR IRRIGATION SYRINGE UNKNOWN manufactured by Unknown.
[16755964]
While nurse was irrigating left ear, the tip of the ear irrigating syringe came off, entering the ear with force, and puncturing pt's eardrum. Required patch to left eardrum placed by ent. Unfortunately, this syringe does not have an imprint of the co who mfg it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002867 |
| MDR Report Key | 14751 |
| Date Received | 1994-07-19 |
| Date of Report | 1994-07-06 |
| Date of Event | 1994-06-28 |
| Date Added to Maude | 1994-07-20 |
| 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 | RISK MANAGER |
| 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 | EAR IRRIGATION SYRINGE |
| Product Code | KCP |
| Date Received | 1994-07-19 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14745 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-19 |