D
Patient 1
THE COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE BLADE WOULD NOT ATTACH TO THE NEEDLE. THE INTUBATION WAS DELAYED UNTIL ANOTHER LARYNGOSCOPE SET WAS OBTAINED FOR PT USE. NO PT INJURY.
MAUDE MDR 3908274
- MDR report key
- 3908274
- Report number
- 1044475-2014-00161
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-05-05
- Date received
- 2014-05-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MARGIE BURTON, RN
- Address
- PO BOX 12600 RTP NC 27709 US
- Phone
- 919-919-9194
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-05-30 | 0 |
Event Narratives#
N
Patient 1
THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION WAS NOT BE CONDUCTED DUE TO LACK OF THE DEVICE SAMPLE. THE DHR (DEVICE HISTORY RECORD) FILE IS NOT AVAILABLE FOR REVIEW IN THE U.S. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. THE COMPLAINT CANNOT BE CONFIRMED. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED. THE ROOT CAUSE CANNOT BE DETERMINED.