Brand Name | ICEROSS COMFORT |
Type of Device | LINER |
Manufacturer (Section D) |
OSSUR HF |
grjothals 1-5 |
reykjavik, 110 |
IC 110 |
|
Manufacturer Contact |
katla
axelsdottir
|
grjothals 1-5 |
reykjavik, 110
|
IC
110
|
|
MDR Report Key | 16239329 |
MDR Text Key | 308065606 |
Report Number | 3003764610-2023-00004 |
Device Sequence Number | 1 |
Product Code |
ISS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
01/25/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/25/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | I-540628 |
Device Catalogue Number | I-540628 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 12/29/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|