MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-03-25 for RUSCH EMERALD FO MILLER BLADE 4 004454400 manufactured by Teleflex.
[4654725]
The complaint is reported as: the customer alleges that the light on the blade is not working. The issue was detected prior to use.
Patient Sequence No: 1, Text Type: D, B5
[12062093]
The device sample was received by the mfr, but the investigation is incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2014-00070 |
| MDR Report Key | 3851607 |
| Report Source | 06,07 |
| Date Received | 2014-03-25 |
| Date of Report | 2014-03-04 |
| Date of Event | 2014-02-26 |
| Date Mfgr Received | 2014-03-04 |
| Date Added to Maude | 2014-06-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN, REG AFFAIRS |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DR. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH EMERALD FO MILLER BLADE 4 |
| Generic Name | LARYNGOSCOPE BLADE (FIBEROPTIC) |
| Product Code | CAL |
| Date Received | 2014-03-25 |
| Returned To Mfg | 2014-03-19 |
| Catalog Number | 004454400 |
| Lot Number | 1135 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RTP NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-25 |