| Brand Name | Chair Alarm Belt |
| Common Device Name | Monitor, Bed Patient |
| Manufacturer (Section D) |
| TIDI Products LLC |
| 570 enterprise drive |
| neenah WI 54956 |
|
| Manufacturer Contact |
|
chris
rahn
|
| 570 enterprise drive |
| neenah, WI 54956
|
|
+1(920)751-4300
|
|
| MDR Report Key | 50241269 |
| Report Number | 2182318-2026-00083 |
| Device Sequence Number | 9753065 |
| Product Code |
KMI
|
| UDI-Device Identifier | 10190676006288 |
| UDI-Public | 10190676006288 |
| Combination Product (Y/N) | N |
| Initial Reporter State | MN |
| Initial Reporter Country | US |
| PMA/510(K) Number | Exempt |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Serviced by Third Party (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
User Facility |
| Type of Report
| Initial |
| Report Date (Section B) |
07/15/2026 |
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
No
|
| Is this a Product Problem Report? |
Yes
|
| Device Model Number | 8399L |
| Device Catalogue Number | 8399L |
| Device Lot Number | Unknown |
| Was Device Available for Evaluation? |
No
|
| Is the Reporter a Health Professional? |
No
|
| Was the Report Sent to FDA? |
No
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 07/15/2026 |
| Initial Report FDA Received Date | 08/13/2026 |
| Was Device Evaluated by Manufacturer? (Y/N) |
No
|
| Is the Device Labeled for Single Use? (Y/N) |
Yes
|
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N) |
No
|
| Patient Sequence Number | 1 |
| Patient Sex | Unknown |
|
|