Brand Name | ICEROSS DERMO LOCKING |
Type of Device | LINER |
Manufacturer (Section D) |
OSSUR HF |
grjothals 1-5 |
reykjavik, |
IC |
|
Manufacturer Contact |
katla
axelsdottir
|
grjothals 1-5 |
reykjavik, 110
|
IC
110
|
|
MDR Report Key | 18738668 |
MDR Text Key | 335751749 |
Report Number | 3003764610-2024-00001 |
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 |
Consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/15/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/20/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | I-431326 |
Device Catalogue Number | I-431326 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 01/22/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Sex | Male |
|
|