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 |