MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-08 for TELEFLEX * 008620100 manufactured by Rusch, Inc..
[634127]
The assistant nurse manager put batteries into a small, penlight-sized laryngoscope handle. The handle immediately began to heat up to the point where it became uncomfortable to hold. The handle was never used on a patient, and was immediately quarantined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 878621 |
| MDR Report Key | 878621 |
| Date Received | 2007-06-08 |
| Date of Report | 2007-06-08 |
| Date of Event | 2007-05-31 |
| Report Date | 2007-06-08 |
| Date Reported to FDA | 2007-06-08 |
| Date Added to Maude | 2007-07-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TELEFLEX |
| Generic Name | LARYNGOSCOPE, HANDLE |
| Product Code | EQN |
| Date Received | 2007-06-08 |
| Returned To Mfg | 2007-06-08 |
| Model Number | * |
| Catalog Number | 008620100 |
| Lot Number | 088238-1OR 082370-1 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 857949 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 4024 STIRRUP CREEK DRIVE SUITE 720 DURHAM NC 27703 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-08 |