MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-08-07 for 4MM VACUUM ASPIRATION CATHETER 4 MM R59524 manufactured by Rocket Medical.
[2978066]
'tip of catheter detached during attempted removal from pt's uterus.
Patient Sequence No: 1, Text Type: D, B5
[10134370]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610632-2006-00001 |
| MDR Report Key | 2760231 |
| Report Source | 05 |
| Date Received | 2006-08-07 |
| Date of Report | 2006-07-17 |
| Date of Event | 2006-06-17 |
| Date Mfgr Received | 2006-06-10 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2012-09-28 |
| 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 Street | WASHINGTON |
| Manufacturer City | TYNE AND WEAR |
| Manufacturer Phone | 14194488 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4MM VACUUM ASPIRATION CATHETER |
| Generic Name | VACUUM ASPIRATION CATHETER VARIOUS |
| Product Code | HFF |
| Date Received | 2006-08-07 |
| Returned To Mfg | 2006-06-15 |
| Model Number | 4 MM |
| Catalog Number | R59524 |
| Lot Number | 404381 |
| Device Expiration Date | 2009-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCKET MEDICAL |
| Manufacturer Address | WASHINGTON TYNE AND WEAR NE389BZ NE38 9BZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-08-07 |