MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-06 for IN-FAST ULTRA * 72403886 manufactured by American Medical Systems, Inc..
[393403]
The suturing device was removed from the package and prepared for patient use. Upon insertion of the device, the surgeon engaged the activation button and the device did not operate. Reported this to the vendor representative and it was felt that there was probably a dead battery. Follow-up reveals that another device was opened and used without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 565415 |
| MDR Report Key | 565415 |
| Date Received | 2005-01-06 |
| Date of Report | 2005-01-06 |
| Date of Event | 2005-01-04 |
| Report Date | 2005-01-06 |
| Date Reported to FDA | 2005-01-06 |
| Date Added to Maude | 2005-01-14 |
| 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 | 0 |
| 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 | IN-FAST ULTRA |
| Generic Name | TRANSVAGINAL BLADDER SUSPENSION SUTURING DEVICE |
| Product Code | FHK |
| Date Received | 2005-01-06 |
| Model Number | * |
| Catalog Number | 72403886 |
| Lot Number | 400746 |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 555187 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-01-06 |