Brand Name | WELCH ALLYN, INC. |
Type of Device | THERMOMETER, ELECTRONIC, CLINICAL |
Manufacturer (Section D) |
WELCH ALLYN, INC. |
4341 state street road |
skaneateles falls NY 13153 |
|
MDR Report Key | 10008951 |
MDR Text Key | 189322565 |
Report Number | 10008951 |
Device Sequence Number | 1 |
Product Code |
FLL
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
04/21/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 901053 |
Device Catalogue Number | 01692-000 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/21/2020 |
Date Report to Manufacturer | 04/29/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 04/29/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|