Brand Name | E-MOTION M15 |
Type of Device | E-MOTION M15 |
Manufacturer (Section D) |
ALBER GMBH |
vor dem weissen stein 14 |
albstadt 72461 |
GM 72461 |
|
Manufacturer (Section G) |
ALBER GMBH |
vor dem weissen stein 14 |
|
albstadt, baden-württemberg, germany 72461 |
GM
72461
|
|
Manufacturer Contact |
christoph
hauschel
|
vor dem weissen stein 14 |
albstadt, baden-württemberg, germany 72461
|
GM
72461
|
|
MDR Report Key | 14998145 |
MDR Text Key | 295770020 |
Report Number | 3004730072-2022-00005 |
Device Sequence Number | 1 |
Product Code |
ITI
|
Combination Product (y/n) | N |
Reporter Country Code | FI |
PMA/PMN Number | K003449 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Inspection |
Type of Report
| Initial |
Report Date |
06/17/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | M15 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/08/2022 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/17/2022 |
Initial Date FDA Received | 07/13/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/04/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
|
|