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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY PRODUCTS LLC POSEY QR FOAM LIMB HOLDER RESTRAINT, PROTECTIVE

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POSEY PRODUCTS LLC POSEY QR FOAM LIMB HOLDER RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2534
Device Problem Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Customer declined to return device. There have been no other complaints received for this part number. However, historical data found complaints for other foam limb holders. Of those returned, excessive force and/or wear and tear has contributed to the malfunction. These restraints are for limiting limb movement only and are not recommended for patients who are or who become highly aggressive, combative, agitated, or suicidal. 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). Device not returned by customer.
 
Event Description
Territory manager informed us of customer's complaint for item 2534. The adjustable strap was able to be loosened, allowing the patient to grab at tubes. The date of the event is unknown and no injuries have been reported.
 
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Brand NamePOSEY QR FOAM LIMB HOLDER
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCTS LLC
5635 peck road
arcadia 91006
Manufacturer Contact
chris rahn
5635 peck road
arcadia, CA 91006
6264433143
MDR Report Key9188279
MDR Text Key162944742
Report Number2020362-2019-00192
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 company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 09/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number2534
Device Catalogue Number2534
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/18/2019
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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