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 2010-07-22 for N/A UNKNOWN manufactured by Ascent Healthcare Solutions.
[1367596]
It was reported that twelve (12) femostop devices would not inflate.
Patient Sequence No: 1, Text Type: D, B5
[8730833]
The complaint facility stated they had 12 femostop devices that would not inflate. No additional information was provided including patient information or condition, procedure dates, or device model numbers. On (b)(4) 2010 ascent did issue a voluntary recall for six (6) different femostop lot numbers. It was confirmed that the complaint facility did received some device from the recalled lot numbers. However, it is unknown if any of these complaint devices were from the recalled lots. The reporting systems monitoring branch did grant ascent a reporting exemption allowing one mdr to be filed for the 12 complaint devices.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056128-2010-00045 |
| MDR Report Key | 1767117 |
| Report Source | 05,06,07 |
| Date Received | 2010-07-22 |
| Date of Report | 2010-07-21 |
| Date Mfgr Received | 2010-06-24 |
| Date Added to Maude | 2011-06-23 |
| 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 | 2010-07-22 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNONW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Address | 10232 SOUTH 51ST STREET PHOENIX AZ 85044 US 85044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-22 |