MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-25 for * manufactured by Acmi Corp..
[516035]
Blade of the optical urethrotome broke off during use. Retrieved without issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036406 |
| MDR Report Key | 751213 |
| Date Received | 2005-08-25 |
| Date of Report | 2005-08-24 |
| Date of Event | 2005-08-11 |
| Date Added to Maude | 2006-08-18 |
| 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 |
| 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 | * |
| Generic Name | ACMI COLD KNIFE |
| Product Code | EZO |
| Date Received | 2005-08-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 739025 |
| Manufacturer | ACMI CORP. |
| Manufacturer Address | * SOUTHBOROUGH MA 017722104 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-25 |