Brand Name | OXYGEN MASK NON-REBR ADLT |
Type of Device | MASK, OXYGEN, NON-REBREATHING |
Manufacturer (Section D) |
UNOMEDICAL S. A. DE C.V |
av. industrial falcon, lote 7, |
parque ind. del norte |
reynosa, tamaulipas 88736 |
MX 88736 |
|
Manufacturer Contact |
jeanette
johnson
|
7900 triad center drive |
suite 400 |
greensboro, NC 27409
|
3365424681
|
|
MDR Report Key | 5484750 |
MDR Text Key | 39843022 |
Report Number | 9680866-2016-00069 |
Device Sequence Number | 1 |
Product Code |
KGB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/11/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 3106-E |
Device Lot Number | 13-32 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/24/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/11/2016
|
Initial Date FDA Received | 03/07/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|