MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-15 for CANNULAIDE UNK manufactured by Beevers Manufacturing And Supply, Inc.
[5097411]
On (b)(6) 2009 beevers manufacturing and supply inc. , (bms) was notified of a complaint that asserts that a cannulaide device caused a breakout of staph infection. Salter labs acquired bms on (b)(6) 2014 and found no record that bms followed-up with the complaint. Multiple (six) additional attempts of contact were made in 2014 without response. The bms distributor advised salter labs that additional training was provided to the end-user medical facility in 2009 and there have been no reports of similar incidents since then. This is the initial and final report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3023468-2014-00004 |
| MDR Report Key | 4179974 |
| Report Source | 07 |
| Date Received | 2014-10-15 |
| Date of Report | 2014-10-15 |
| Date of Event | 2009-03-24 |
| Date Mfgr Received | 2009-03-24 |
| Date Added to Maude | 2014-10-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | AURELIA BROWNRIDGE |
| Manufacturer Street | 2365 CAMINO VIDA ROBLE |
| Manufacturer City | CARLSBAD CA 92011 |
| Manufacturer Country | US |
| Manufacturer Postal | 92011 |
| Manufacturer Phone | 7607957102 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CANNULAIDE |
| Generic Name | CANNULAIDE |
| Product Code | NHJ |
| Date Received | 2014-10-15 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEEVERS MANUFACTURING AND SUPPLY, INC |
| Manufacturer Address | 850 SW BOOTH BEND ROAD MCMINNVILLE OR 97128 US 97128 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-15 |