Brand Name | NA |
Type of Device | RESPIRATOR, DECONTAMINATED |
Manufacturer (Section D) |
BATTELLE MEMORIAL INSTITUTE |
505 king ave |
columbus OH 43201 |
|
Manufacturer Contact |
carl
smerdel
|
505 king ave |
columbus, OH 43201
|
6144247950
|
|
MDR Report Key | 10801492 |
MDR Text Key | 215076589 |
Report Number | 1523658-2020-00160 |
Device Sequence Number | 1 |
Product Code |
QKY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/05/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/06/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 08/19/2020 |
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? |
Yes
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|