MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-03-20 for RUSCH MRI COND FIBER OPTIC LARYN KIT 005852300 manufactured by Teleflex Medical.
[16850208]
The customer alleges that the device does not work. The alleged issue detected during pre-testing.
Patient Sequence No: 1, Text Type: D, B5
[17190716]
Qn# (b)(4). The device sample was not returned for eval at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2015-00140 |
| MDR Report Key | 4627814 |
| Report Source | 06,07 |
| Date Received | 2015-03-20 |
| Date of Report | 2014-02-24 |
| Date of Event | 2015-02-24 |
| Date Mfgr Received | 2014-02-24 |
| Date Added to Maude | 2015-05-06 |
| 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 | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD. |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| 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 | OGH |
| Date Received | 2015-03-20 |
| 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 MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-20 |