MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-03-06 for RUSCH MRI COND FIBER OPTIC LARYN KIT 005852300 manufactured by Teleflex.
[4406320]
The complaint is reported as: the blades do not illuminate at all times and some do not function at all. The alleged issues was detected during testing of the device. The customer reports that they disposed of two batteries that were not functioning.
Patient Sequence No: 1, Text Type: D, B5
[12011554]
The device sample was not returned for eval at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2014-00049 |
| MDR Report Key | 3837911 |
| Report Source | 06,07 |
| Date Received | 2014-03-06 |
| Date of Report | 2014-02-10 |
| Date of Event | 2014-02-10 |
| Date Mfgr Received | 2014-02-10 |
| Date Added to Maude | 2014-06-16 |
| 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 |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH MRI COND FIBER OPTIC LARYN KIT |
| Generic Name | LARYNGOSCOPE KIT |
| Product Code | CAL |
| Date Received | 2014-03-06 |
| Catalog Number | 005852300 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RTP NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-06 |