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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY PRODUCTS LLC LOCKING TWICE-AS-TOUGH CUFFS RESTRAINT, PROTECTIVE

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POSEY PRODUCTS LLC LOCKING TWICE-AS-TOUGH CUFFS RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2798
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bruise/Contusion (1754)
Event Type  Injury  
Manufacturer Narrative
Associated with medwatches 202036-2018-00025 and 2020362-2018-00027. Product was received in by manufacturer, but at the time of this report, the evaluation has not concluded yet. Therefore, this report is based solely on the information provided by the customer. 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 warranted. Manufacturer reference file #(b)(4).
 
Event Description
Customer reported a patient was able to break the straps by rocking the bed back and forth. He was able to free his left arm the 1st and 2nd time. The 3rd time he was able to free his right arm. Because the patient was able to free himself he punched an officer in the head who suffered bruising. The date the issue occurred is not known. Additional information provided stated the officer received minor medical treatment and has since returned to work with no further issues.
 
Manufacturer Narrative
Additional information provided by the customer stated the officer was received minor medication treatment and has since returned to work with no further issues. Analysis confirmed customer's complaint of the strap breaking. Tensile testing was performed on the product and on new samples, but a root cause analysis could not be determined. It is possible constant tensile strength applied to the product over time may have an effect on the stitching which may cause the threads to degrade and the stitching to weaken over time. Lot number of product indicated this unit had been manufactured over 4 years ago with signs of previous use. The device was lined with lint, dirt and other particles. The hook and loop portion was also fraying. It is likely that wear and tear contributed to the failure. Historical review of the complaint database showed 5 other events where similar products suffered the same stitching/thread issues. Failure analysis showed possible causes was from wear and tear. No serious injury was associated with any of events. 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. 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. " therefore, not corrective or preventive actions are necessary. All complaint 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. Manufacturer reference file # (b)(4).
 
Event Description
Supplemental required for additional information.
 
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Brand NameLOCKING TWICE-AS-TOUGH CUFFS
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCTS LLC
5635 peck rd
arcadia 91006
MDR Report Key7463479
MDR Text Key106589281
Report Number2020362-2018-00028
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
PMA/PMN Number
K963413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 05/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2798
Device Catalogue Number2798
Device Lot Number3154T39
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 04/26/2018 Patient Sequence Number: 1
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