MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-28 for TELEFLEX - RUSCH GREENSPEC LARYNGOSCOPE HANDLE manufactured by Teleflex Medical.
[129031122]
Handle / blade folded in an emesis basin in anesthesia cart ready to be used. Smelled hot plastic and handle very hot - unable to touch. No packaging saved - unable to determine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081690 |
| MDR Report Key | 8115429 |
| Date Received | 2018-11-28 |
| Date Added to Maude | 2018-11-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TELEFLEX - RUSCH GREENSPEC LARYNGOSCOPE HANDLE |
| Generic Name | LARYNGOSCOPE NON-RIGID |
| Product Code | CAL |
| Date Received | 2018-11-28 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | DUBLIN RD ATHLONE CO., WESTMEATH EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-28 |