Brand Name | SOCLEAN 2 |
Type of Device | SLEEP EQUIPMENT MAINTENANCE SYSTEM |
Manufacturer (Section D) |
SOCLEAN, INC. |
12 vose farm road |
peterborough NH 03458 |
|
Manufacturer (Section G) |
SOCLEAN, INC. |
12 vose farm road |
|
peterborough NH 03458 |
|
Manufacturer Contact |
anne
nadeau
|
12 vose farm road |
peterborough, NH 03458
|
6033712533
|
|
MDR Report Key | 12530625 |
MDR Text Key | 273314193 |
Report Number | 3009534409-2021-00034 |
Device Sequence Number | 1 |
Product Code |
LRJ
|
UDI-Device Identifier | 00187293000860 |
UDI-Public | 187293000860 |
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 |
Report Date |
08/23/2021 |
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 | SC1200 |
Device Catalogue Number | SC1200 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/18/2020 |
Initial Date Manufacturer Received |
03/02/2020 |
Initial Date FDA Received | 09/24/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/01/2019 |
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) |
Other;
|
|
|