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 2010-07-14 for N/A 11165 manufactured by Ascent Halthcare Solutions.
[19614729]
This mdr is associated with an ascent voluntary recall for six (6) femostop lot numbers where the device may fail to inflate properly and may leak due to a seal separation between the dome and plastic arch base. Initially this was not considered a mdr reportable event because there was no patient injury, medical intervention was not required, and ascent had no history of any patient injury due to this type of malfunction. On june 18th ascent initiated a voluntary recall for the six femostop lot numbers so this mdr is being filed due to the recall. The patient information and procedure date were not provided to ascent.
Patient Sequence No: 1, Text Type: N, H10
[19844558]
It was reported that the device would not hold pressure. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056128-2010-00031 |
| MDR Report Key | 1756451 |
| Report Source | 05,06,07 |
| Date Received | 2010-07-14 |
| Date of Report | 2010-07-14 |
| Date Mfgr Received | 2010-06-18 |
| Device Manufacturer Date | 2009-11-30 |
| 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 | 2010-07-14 |
| Returned To Mfg | 2010-03-19 |
| Model Number | 11165 |
| Catalog Number | 11165 |
| Lot Number | 879990 |
| 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 | 2010-07-14 |