Brand Name | HOT PACK INSTANT |
Type of Device | PACK, HOT OR COLD, DISPOSABLE |
Manufacturer (Section D) |
CARDINAL HEALTH 200, LLC |
3651 birchwood drive |
waukegan IL 60085 |
|
MDR Report Key | 11612826 |
MDR Text Key | 243752507 |
Report Number | 11612826 |
Device Sequence Number | 1 |
Product Code |
IMD
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/30/2021 |
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 |
Health Professional
|
Device Model Number | 11443-512B |
Device Catalogue Number | 11443-512B |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/30/2021 |
Date Report to Manufacturer | 04/05/2021 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/05/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 24820 DA |
|
|