Brand Name | PRODIGY MINI-MIST NEBULIZER |
Type of Device | PORTABLE NEBULIZER |
Manufacturer (Section D) |
OK BIOTECH CO., LTD. |
no. 91, sec. 2, |
gongdao 5th road |
hsinchu, 30070 |
TW 30070 |
|
Manufacturer (Section G) |
OK BIOTECH CO., LTD. |
no. 91, sec. 2, |
gongdao 5th road |
hsinchu, 30070 |
TW
30070
|
|
Manufacturer Contact |
joanna
wang
|
no. 91, sec. 2, |
gongdao 5th road |
hsinchu, 30070
|
TW
30070
|
|
MDR Report Key | 6600315 |
MDR Text Key | 76251701 |
Report Number | 3005862821-2017-00042 |
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 |
04/04/2017 |
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? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 32500A |
Device Catalogue Number | 32500A |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/01/2017 |
Initial Date FDA Received | 05/31/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/15/2010 |
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 | ALBUTEROL; ASTHMA (NAC); GENERIC FLEXERIL (MUSCLE RELAXER); IBUPROFEN 800 MG |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 35 YR |
Patient Weight | 104 |
|
|