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U.S. Department of Health and Human Services

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

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TIDI PRODUCTS UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF, LARGE RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2700QL
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Tm reporting incident of restraint ripping while in use. Patient was able to get out of restraint. The date the issue was discovered is unknown and no patient incident or injury was reported.
 
Manufacturer Narrative
Evaluation summary: visual findings observed 1 single wrist restraint was returned, sold in pairs. The red hook fastener is torn. No issues found with the two quick-release buckles. No issues found to the webbing for the wrist cuff and bed-connecting strap. All labels are present and legible. Evaluation found the torn red hook fastener (fastening tape) cuff appears to have originated at the box stitch that secures the webbing to the hook fastener. The box stitch is intact and the red hook fastener sewn with the box stitch has torn suggesting excessive force was applied resulting in the failure. The root cause could not be determined only suggested possible causes such as product applied to a combative patient who exerted enough force beyond the threshold to cause the failure, or an application issue. Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. The ifu states before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch, cracked or broken buckles or locks, and/or that hook-and-loop adheres securely, as these may allow patient to remove cuff. Discard if device is damaged. Do not use this device on a patient who is or becomes suicidal, highly aggressive or combative, self-destructive, or deemed to be an immediate risk to others, unless the patient is under constant supervision. 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 warning 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 warrant. Manufacturer reference file (b)(4).
 
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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 Key14112287
MDR Text Key298804109
Report Number2182318-2022-00027
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 03/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number2700QL
Device Catalogue Number2700QL
Device Lot Number1306T041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2022
Was the Report Sent to FDA? No
Date Manufacturer Received03/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2021
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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