• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

POSEY PRODUCT LLC FOAM LIMB HOLDER RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2532
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Emotional Changes (1831)
Event Date 04/08/2017
Event Type  malfunction  
Manufacturer Narrative
(other) - product was discarded by the customer and is not available for return. The customer had been compiling a list of incidents related to the soft limb holder as justification to upper management to consider switching to an alternative restraint. The customer is fully aware that the restraint is being used outside of the recommended instructions for use and thus decided not to report individual incidents to posey. Posey became aware by accident because the hospital forwarded the list of issues to a posey representative. This is a soft foam limb holder for limiting limb movement. It is contraindicated for the patient who is or becomes highly aggressive, combative, agitated, or suicidal. Additional or different body or limb restraints may be needed: if the patient pulls violently against the bed straps; to reduce the risk of the patient getting access to the line/wound/tube site; to prevent the patient from flailing or bucking up and down causing self-injury. A restraint must only be used in accord with the patient¿s individualized care plan (icp). Just as patient behavior is not 100% predictable, no product is 100% fool-proof. Patient safety requires regular reassessment and monitoring per facility policy. A product that worked in the past may be inappropriate if the patient¿s mental or physical health status changes. Never apply any product that you feel is unsafe. Consult with the proper medical authority if you have questions about patient safety. The patient was diagnosed with agitation and became combative. As a result, the patient was able to get out of the restraint. 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). Device discarded.
 
Event Description
Customer reported patient got out of the restraint. Patient was agitated then became combative.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFOAM LIMB HOLDER
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCT LLC
5635 peck rd
arcadia CA 91006
Manufacturer Contact
william hincy
posey company
5635 peck road
arcadia, CA 91006
6264433143
MDR Report Key6699303
MDR Text Key79773423
Report Number2020362-2017-00041
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 health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 06/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2532
Device Catalogue Number2532
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2017
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

-
-