Brand Name | ADULT NASAL CANNULA WITH 7 FT. STAR LUMEN TUBI |
Type of Device | CANNULA, NASAL, OXYGEN |
Manufacturer (Section D) |
UNOMEDICAL S.A. DE C.V. |
av. industrial falcon secc. 4 |
lote 7, parque ind. del norte |
reynosa, tams. 88736 |
MX 88736 |
|
Manufacturer (Section G) |
CONVATEC |
211 american ave |
|
greensboro NC 27409 |
|
Manufacturer Contact |
matthew
walenciak
|
211 american ave |
greensboro, NC 27409
|
9083779293
|
|
MDR Report Key | 4996499 |
MDR Text Key | 23655760 |
Report Number | 9680866-2015-00075 |
Device Sequence Number | 1 |
Product Code |
CAT
|
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 |
Not Applicable
|
Report Date |
07/21/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/10/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/01/2019 |
Device Model Number | H1820 |
Device Lot Number | 107391 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/04/2015 |
Date Manufacturer Received | 09/04/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/01/2014 |
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 |
|
|