MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-10-16 for RUSCH RI FIBER-OPTIC LARYNGOSCOPE KIT 005852300 manufactured by Teleflex.
[5160642]
The complaint alleges that the handle stopped working. There were no reports of patients harm or injury.
Patient Sequence No: 1, Text Type: D, B5
[12476973]
A device history record (dhr) review could not be performed as the lot number was unknown. The sample was not returned for evaluation, therefore, the complaint could not be confirmed. If the sample is received, a follow-up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2014-00285 |
| MDR Report Key | 4188203 |
| Report Source | 06,07 |
| Date Received | 2014-10-16 |
| Date of Report | 2014-09-29 |
| Date of Event | 2014-09-26 |
| Date Mfgr Received | 2014-09-29 |
| Date Added to Maude | 2014-10-30 |
| 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 | KATHARINE TARPLAY, REGULATORY AFFAI |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334854 |
| 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 RI FIBER-OPTIC LARYNGOSCOPE KIT |
| Generic Name | MRI LARYNGOSCOPE KIT |
| Product Code | OGH |
| Date Received | 2014-10-16 |
| 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 | RESERACH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-16 |