Brand Name | ADULT HIGH CONCENTRATION REBREATHER , OXYGEN MASK |
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 (Section G) |
CONVATEC, INC. |
211 american avenue |
|
greensboro NC 27409 |
|
Manufacturer Contact |
jeanette
johnson
|
7900 triad center drive |
suite 400 |
greensboro, NC 27409
|
3365424681
|
|
MDR Report Key | 5265258 |
MDR Text Key | 32642626 |
Report Number | 9680866-2015-00112 |
Device Sequence Number | 1 |
Product Code |
KGB
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
11/18/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/03/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 104-E |
Device Lot Number | 108658 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 12/14/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
|
|