Brand Name | SOCLEAN2 |
Type of Device | DISINFECTANT, MEDICAL DEVICES |
Manufacturer (Section D) |
|
MDR Report Key | 13862791 |
MDR Text Key | 287886359 |
Report Number | MW5108446 |
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 |
Voluntary
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
03/21/2022 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | SC1200 |
Device Lot Number | 2020-06-12 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/22/2022 |
Patient Sequence Number | 1 |
Treatment | CPAP |
Patient Outcome(s) |
Disability;
|
Patient Age | 60 YR |
Patient Sex | Male |
Patient Weight | 118 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |
|
|