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U.S. Department of Health and Human Services

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

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POSEY PRODUCTS LLC FOAM LIMB HOLDER RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2532
Device Problem Break (1069)
Patient Problem Bruise/Contusion (1754)
Event Date 07/12/2018
Event Type  Injury  
Manufacturer Narrative
Customer confirmed the device was discarded and will not be returning to manufacturer for analysis. This event is reported solely on the information provided by the customer. An investigation of our complaint file found other complaints where the quick-release buckle breaking resulted in patient release. However, most of the breakage were related to the prong of a male portion of the buckle. There are no other complaint where the breakage was at the same spot indicated by the customer (back of the buckle). At this time, this appears to be an isolated situation. A review of 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. (b)(4).
 
Event Description
Customer reported a staff member was hit by a patient using the foam limb holder. It was stated the plastic clip broke on the connecting strap where it is not around the waist. Additional information was provided by a voluntary medwatch report received on 07/30/2018 and by a follow-up email on 07/31/2018. Patient broke free of his ankle restraint where a nurse was then treated in the er for a bruise on her hand.
 
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Brand NameFOAM LIMB HOLDER
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCTS LLC
5635 peck rd
arcadia CA 91006
Manufacturer Contact
william hincy
posey company
5635 peck road
arcadia, CA 91006
6264433143
MDR Report Key7741750
MDR Text Key115764955
Report Number2020362-2018-00063
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 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2532
Device Catalogue Number2532
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 Received07/12/2018
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

Patient Treatment Data
Date Received: 08/02/2018 Patient Sequence Number: 1
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