Brand Name | OXYGEN AND AEROSOL THERAPY |
Type of Device | MASK, OXYGEN, NON-REBREATHING |
Manufacturer (Section D) |
UNOMEDICAL S.A. DE C.V. |
av. industrial falcon secc. 4 |
lote 7, parque ind. del norte |
reynosa, tams. 8873 6 |
MX 88736 |
|
Manufacturer Contact |
matthew
walenciak, int.assoc.dir.
|
211 american ave. |
greensboro, NC 27409
|
9083779293
|
|
MDR Report Key | 4344923 |
MDR Text Key | 16851642 |
Report Number | 9680866-2014-00043 |
Device Sequence Number | 1 |
Product Code |
KGB
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
11/12/2014 |
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 Expiration Date | 06/01/2019 |
Device Model Number | 3106-E |
Device Lot Number | 104902 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/12/2014
|
Initial Date FDA Received | 12/08/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|