MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-07-20 for XP-4000-01 manufactured by Ascent Healthcare Solutions.
[672624]
During the procedure, the handel broke. There was no serious injury reported.
Patient Sequence No: 1, Text Type: D, B5
[7807582]
The eval of the device and the completion of this report are on hold until the device can be evaluated. A follow-up report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090040-2007-00010 |
| MDR Report Key | 883896 |
| Report Source | 05,07 |
| Date Received | 2007-07-20 |
| Date of Report | 2007-07-20 |
| Date of Event | 2007-06-22 |
| Date Mfgr Received | 2007-06-22 |
| Date Added to Maude | 2007-07-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MOIRA BARTON-VARTY |
| Manufacturer Street | 10232 SOUTH 51ST ST. |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal | 85044 |
| Manufacturer Phone | 4807635300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Product Code | NQG |
| Date Received | 2007-07-20 |
| Returned To Mfg | 2007-07-18 |
| Model Number | XP-4000-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 863040 |
| Manufacturer | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Address | PHOENIX AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-07-20 |