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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TIDI PRODUCTS LOCKING TWICE-AS-TOUGH CUFFS ANKLE RESTRAINT, PROTECTIVE

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TIDI PRODUCTS LOCKING TWICE-AS-TOUGH CUFFS ANKLE RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2793
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Customer reported via email, they had a patient who was able to tear the cuff. Customer no longer has this product, only provided a photo.
 
Manufacturer Narrative
This report is based solely on the information provided by the customer. Due to product not being returned, reported issue cannot be determined with only the information available. A historical review of the complaint database for part 2793, did not find any other similar complaint. At this time, there is no manufacturing non-conformity found. 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, 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 or if unable to lock. Do not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self. At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use (ifu) 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). Product not returned.
 
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Brand NameLOCKING TWICE-AS-TOUGH CUFFS ANKLE
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 Key14932711
MDR Text Key298308098
Report Number2182318-2022-00076
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 06/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number2793
Device Catalogue Number2793
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/08/2022
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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