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 2010-05-07 for N/A 11165 manufactured by Ascent Halthcare Solutions.
[1500746]
It was reported that the device was tested before the surgery and was found to be leaking. The device was not used on the patient and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8647107]
At the time of this report the device investigation had not been completed. Once the investigation is completed a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056128-2010-00012 |
| MDR Report Key | 1677122 |
| Report Source | 05,06,07 |
| Date Received | 2010-05-07 |
| Date of Report | 2010-07-15 |
| Date of Event | 2010-04-12 |
| Date Mfgr Received | 2010-06-18 |
| Device Manufacturer Date | 2009-11-30 |
| Date Added to Maude | 2011-06-24 |
| 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 | MS. MOIRA BARTON-VARTY |
| Manufacturer Street | 10232 S. 51ST STREET |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal | 85044 |
| Manufacturer Phone | 4807635300 |
| Manufacturer G1 | ASCENT HALTHCARE SOLUTIONS |
| Manufacturer Street | 5307 GREAT OAK DRIVE |
| Manufacturer City | LAKELAND FL 33815 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33815 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | NMF |
| Product Code | NMF |
| Date Received | 2010-05-07 |
| Returned To Mfg | 2010-04-21 |
| Model Number | 11165 |
| Catalog Number | 11165 |
| Lot Number | 880274 |
| Device Expiration Date | 2010-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENT HALTHCARE SOLUTIONS |
| Manufacturer Address | 5307 GREAT OAK DRIVE LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-07 |