MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-07-01 for RUSCH MRI COND FIBER OPTIC LARYN KIT 005852300 manufactured by Teleflex Medical.
[6024386]
The customer alleges that the light bundle will not light on the mac 2 blade. Intubation was accomplished with a standard laryngoscope set. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[14146580]
(b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[23957567]
(b)(4). The sample was not returned for evaluation; therefore, the complaint could not be confirmed. If the sample is returned, a follow-up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
[23957568]
The customer alleges that the light bundle will not light on the mac 2 blade. Intubation was accomplished with a standard laryngoscope set. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1044475-2015-00216 |
| MDR Report Key | 4884497 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-07-01 |
| Date of Report | 2015-06-17 |
| Date of Event | 2014-06-18 |
| Date Mfgr Received | 2015-08-20 |
| Date Added to Maude | 2015-07-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 2917 WECK DRIVE |
| 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 | MRI LARYNGOSCOPE KIT |
| Product Code | OGH |
| Date Received | 2015-07-01 |
| Catalog Number | 005852300 |
| Lot Number | 132601 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-01 |