FDA Adverse Event
Malfunction
Summary report: N
NASAL OXYGEN CANNULA
MDR report key: 4110874
·
Received September 16, 2014
Report
- Report Number
- 9680866-2014-00027
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Date of Event
- August 26, 2014
- Report Date
- August 26, 2014
- Manufacturer
- UNOMEDICAL S.A. DE C.V.
- Product Code
- CAT
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PER THE COMPLAINT, THERE WAS NO PRODUCT CONTACT WITH THE END USER. NO SAMPLE WAS PROVIDED, HOWEVER, A PHOTOGRAPH WAS PROVIDED TO AID IN THE INVESTIGATION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED A BUG WAS INSIDE THE CANNULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573840 | NASAL OXYGEN CANNULA | CANNULA, NASA, OXYGEN 73 CAT | CAT | UNOMEDICAL S.A. DE C.V. | LM-86-331 | 13-14 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |