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U.S. Department of Health and Human Services

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

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POSEY PRODUCTS LLC NON-LOCKING TWICE-AS-TOUGH ANKLE CUFF RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2791
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Customer declined to return device. Historical review of the complaint database found 4 other event with similar issue where the patients were able to release from the restraint. Of the 4 complaints, product was returned for two of the complaints. In both instances, the product was not being used per the instructions for use (ifu). Analysis of one device found it to have a box stitch that was sewn with a high amount of tension that had failed over time, possibly due to incorrect sewing machine settings. There was no patient injury involved in any of the complaints. Sample evaluation found no evidence of manufacturing concern and historical review does not show a trend of product malfunction. The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. It is recommended that the restraint not be used on patient who is or becomes highly aggressive, combative, agitated or suicidal. The ifu also provided extra warning to always monitor patient per facility policy. Be aware that constant monitoring may be required for: aggressive or agitated patients; and patients deemed at risk of aspirating their vomit. This includes patients in the supine position, or who are not able to sit up. If the patient vomits, he or she could aspirate the vomit and suffocate. Be prepared to intervene at the first sign of danger. Such patients require frequent review and evaluation of their physical and psychological status. Without return of the device the reported issue could not be confirmed and without the device lot information the release documentation could not be reviewed. 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. Manufacturer reference file # (b)(4).
 
Event Description
Customer reported while the patient is in use with the restraint the patient is able to release themselves from the restraint. The date the issue was discovered is unknown and no patient incident or injury was reported.
 
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Brand NameNON-LOCKING TWICE-AS-TOUGH ANKLE CUFF
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCTS LLC
5635 peck road
arcadia CA 91006
Manufacturer Contact
william hincy
5635 peck road
arcadia, CA 91006
6264433143
MDR Report Key8660613
MDR Text Key146812681
Report Number2020362-2019-00132
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 05/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2791
Device Catalogue Number2791
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/01/2019
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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