MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-17 for * manufactured by Storz.
[310421]
During an eye procedure in 2004, the tip of kuglan - hook broke in the eye. The broken tip was retrieved. There were no pt complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031563 |
| MDR Report Key | 519471 |
| Date Received | 2004-03-17 |
| Date of Report | 2004-03-17 |
| Date of Event | 2004-01-28 |
| Date Added to Maude | 2004-04-09 |
| 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 | 3 |
| 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 | * |
| Generic Name | KUGLAN-HOOK-STORZ |
| Product Code | HNQ |
| Date Received | 2004-03-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | REF. E0567 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 508536 |
| Manufacturer | STORZ |
| Manufacturer Address | 3365 TREE COURT INDUST BLVD ST. LOUIS MO 63122 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-03-17 |