MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-14 for STORZ manufactured by Storz.
[137144]
Pt had insect in ear. Irrigation syringe came apart and the tip of it went into the pt's ear when the nurse tried to remove the insect there was perforation to the tympanic membrane.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 240388 |
| MDR Report Key | 240388 |
| Date Received | 1999-09-14 |
| Date of Report | 1999-08-17 |
| Date of Event | 1999-07-17 |
| Date Facility Aware | 1999-07-17 |
| Report Date | 1999-08-17 |
| Date Added to Maude | 1999-09-20 |
| 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 |
| 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 | STORZ |
| Generic Name | STAINLESS STEEL IRRIGATION SYRINGE |
| Product Code | KCP |
| Date Received | 1999-09-14 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 232926 |
| Manufacturer | STORZ |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-09-14 |