MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-10-09 for 8065790020 manufactured by Ascent Healthcare Solutions.
[979492]
It was reported that the phaco tip broke off in the patient's eye. It was removed by the physician. No injury to the patient or adverse event was reported.
Patient Sequence No: 1, Text Type: D, B5
[8213116]
The used device has been returned; however, a device analysis has not yet been completed. Upon completion of the investigation, a follow-up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090040-2008-00006 |
| MDR Report Key | 1205177 |
| Report Source | 05,06,07 |
| Date Received | 2008-10-09 |
| Date of Report | 2008-10-09 |
| Date of Event | 2008-09-11 |
| Date Mfgr Received | 2008-09-11 |
| Device Manufacturer Date | 2008-07-22 |
| Date Added to Maude | 2009-03-05 |
| 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 | 0 |
| 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 | NKX |
| Date Received | 2008-10-09 |
| Returned To Mfg | 2008-09-19 |
| Model Number | 8065790020 |
| Catalog Number | 8065790020 |
| ID Number | 372107F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Address | PHOENIX AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-09 |