Brand Name | COLD THERAPY |
Type of Device | COLD THERAPY PAD |
Manufacturer (Section D) |
CINCINNATI SUB-ZERO PRODUCTS, LLC |
12011 mosteller road |
cincinnati OH 45241 |
|
MDR Report Key | 8171385 |
MDR Text Key | 130628174 |
Report Number | 1516825-2018-00027 |
Device Sequence Number | 1 |
Product Code |
ILO
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Type of Report
| Initial,Followup |
Report Date |
12/12/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/17/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | CT-99 |
Device Lot Number | 16640 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 10/09/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|