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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 Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Product is scheduled to be returned, but has not been received by manufacturer at the time of this report. 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 provided adequate instructions and warning for the safe and effective use of the device. Therefore, no corrective or preventive 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). No product returned at this time.
 
Event Description
Got a complaint from a (b)(6) that was reported to her. The rn states that when a patient pulled on the strap the adjustable part lengthened. I have limited other information regarding this incident. The date the issue was discovered is unknown and no patient incident or injury was reported.
 
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Brand NameFOAM LIMB HOLDER
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 Key8951713
MDR Text Key162944081
Report Number2020362-2019-00180
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,Followup,Followup
Report Date 10/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2532
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 Received10/04/2019
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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