Brand Name | PRODIGY MINI-MIST PORTABLE NEBULIZER |
Type of Device | MINI-MIST PORTABLE NEBULIZER |
Manufacturer (Section D) |
OK BIOTECH CO., LTD. |
no. 91, sec. 2, |
gongdao 5th road |
hsinchu, taiwan 30070 |
TW 30070 |
|
Manufacturer (Section G) |
OK BIOTECH CO., LTD. |
no. 91, sec. 2, |
gongdao 5th road |
hsinchu, taiwan 30070 |
TW
30070
|
|
Manufacturer Contact |
joanna
wang
|
no. 91, sec. 2 |
gongdao 5th road |
hsinchu, taiwan 30070
|
TW
30070
|
3 5160258
|
|
MDR Report Key | 6123722 |
MDR Text Key | 61027152 |
Report Number | 3005862821-2016-00099 |
Device Sequence Number | 1 |
Product Code |
CAF
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K090307 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
10/09/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Model Number | 32500A |
Device Catalogue Number | 32500A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/16/2016 |
Initial Date Manufacturer Received |
10/26/2016
|
Initial Date FDA Received | 11/23/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/03/2011 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | LISINOPRIL; MELOXICAM; METFORMIN; SINGULAIR |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 52 YR |
Patient Weight | 115 |
|
|