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Model Number 2799
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Customer reported via email the restraint broke at the strap to cuff area where the stitching is. Patient was average size and not on drugs but was psychotic. The date the issue was discovered is unknown and no patient incident or injury was reported.
Manufacturer Narrative
Evaluation summary visual findings observed one single 2799 restraint returned (sold in pairs). No keys were returned. Restraint was received in 2 pieces - detached at the box stitch which secures the bed connecting strap. Lint found in the red and black hooks. Scratches and indentations found on both key-lock buckles. Fuzzy/frayed edges observed the black webbing. Labeling is present and legible. Evaluation found that the square box stitch which secures the bed-connecting to the cuff are coming apart. The broken stitches are located in-between the webbing of the wrist strap and the overlapped bed-connecting strap. Close inspection of the box x stitch shows the top and bottom of the stitch remains complete/intact, and the broken or loose threads are contained within the plies of the webbing. Observing the ends of the threads through magnified glasses, there is a combination of threads that appear to have been pulled and threads that may have been cut. The broken threads at the box stitch have been identified as the failure and was the result of tensile forces applied beyond the threshold of the box stitch strength, but the root cause cannot be determined because there was not enough information provided by the customer. Per the ifu states 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. 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. 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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Manufacturer (Section D)
570 enterprise dr
neenah WI 54956
Manufacturer Contact
chris rahn
570 enterprise drive
neenah, WI 54956
MDR Report Key14162513
MDR Text Key290556889
Report Number2182318-2022-00031
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number2799
Device Catalogue Number2799
Device Lot Number1287T044
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2022
Was the Report Sent to FDA? No
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown