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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TIDI Products LLC Chair Alarm Belt; Monitor, Bed Patient

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TIDI Products LLC Chair Alarm Belt; Monitor, Bed Patient Back to Search Results
Model Number 8399L
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
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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 Key50241269
Report Number2182318-2026-00083
Device Sequence Number9753065
Product Code KMI
UDI-Device Identifier10190676006288
UDI-Public10190676006288
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
Exempt
Number of Events Summarized1
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 Number8399L
Device Catalogue Number8399L
Device Lot NumberUnknown
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 Date08/13/2026
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 Number1
Patient SexUnknown
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