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U.S. Department of Health and Human Services

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

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TIDI PRODUCTS QUICK-RELEASE TWICE-AS-TOUGH CUFFS RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2791Q
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Customer reported via email they had an incident with our restraints. The security manager attempt to apply foot restraints to an aggressive patient. The clip on the restraints snapped off which caused the restraints to be removed from patients foot. Talked with customer, they advised it was disposed of and unrecoverable.
 
Manufacturer Narrative
Customer confirmed the product will not be returning for analysis. Therefore, this event is reported based on the information provided by the customer. A review of the complaint database revealed some potential causes from similar issues reported and evaluated. Of those returned, excessive force, misuse of the device, and small voids / holes have been found in the buckles. The units with the void / hole in the buckle, a sample pull test was performed with the same raw material used on the restraints. The pull test result did not present a low yield that would suggest a manufacturing process of the buckle may have contributed to the reported issue. All units passed the pull test requirement as the minimum pull force was 207. 02 lbs. And the maximum force was 473. 28 lbs. With an average of 284. 96 lbs. Although these potential findings could be a similar result of the reported issue it cannot be determined without the device being returned for evaluation. At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device. Therefore, no corrective or preventative actions are necessary. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted. Manufacture reference file (b)(4).
 
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Brand NameQUICK-RELEASE TWICE-AS-TOUGH CUFFS
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 Key14746687
MDR Text Key294518966
Report Number2182318-2022-00063
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 05/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number2791Q
Device Catalogue Number2791Q
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/23/2022
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

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