D
Patient 1
THE COMPLAINT IS REPORTED AS: THE CUFF ON THE TUBE IS DEFLATING AND CREATING LEAKS DURING PATIENT USE. THE CUFF HAD TO BE REINFLATED AND MONITORED. NO PATIENT INJURY REPORTED.
MAUDE MDR 2889104
- MDR report key
- 2889104
- Report number
- 3003898360-2012-00614
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-12-07
- Date received
- 2012-12-21
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- KATHARINE TARPLEY
- Address
- P. O. BOX 12600 RTP NC 27709 US
- Phone
- 919-919-9194
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-12-21 | 0 |
Event Narratives#
N
Patient 1
THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE DEVICE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE ESTABLISHED. MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.