• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TIDI PRODUCTS UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF, LARGE RESTRAINT, PROTECTIVE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TIDI PRODUCTS UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF, LARGE RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2700QL
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  malfunction  
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF, LARGE
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
TIDI PRODUCTS
570 enterprise dr
neenah WI 54956
Manufacturer Contact
chris rahn
570 enterprise drive
neenah, WI 54956
9207514300
MDR Report Key14490847
Report Number2182318-2022-00048
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
 K963413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number2700QL
Device Catalogue Number2700QL
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-