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U.S. Department of Health and Human Services

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

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POSEY COMPANY FOAM LIMB HOLDER RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2532
Device Problem Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device not available.
 
Event Description
The customer reported that there is a slippage issue when the restraint is filled with fluid. The patient is able to maneuver there way out. The date the issue was discovered is unknown and no patient injuries were reported.
 
Manufacturer Narrative
Evaluation results: it has been confirmed that the product will not be returned as it has been discarded. Without the return of the product for evaluation, and without clarification of the reported issue the root cause cannot be determined. Historical data was reviewed; however, it did not reveal any similar instances of moisture causing "slippage" issues for this particular device. The instructions for use warn the user that, "this device is designed for use in normal indoor environments. This device may be stored in ambient warehouse temperatures at normal humidity levels. Avoid excess moisture or high humidity that may damage product materials. " 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
Supplemental medwatch required for additional information.
 
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Brand NameFOAM LIMB HOLDER
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY COMPANY
5635 peck rd.
arcadia CA 91006
Manufacturer Contact
william hincy
posey company
5635 peck road
arcadia, CA 91006
6264433143
MDR Report Key6553121
MDR Text Key74896284
Report Number2020362-2017-00013
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,Followup
Report Date 05/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2017
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 Received05/23/2017
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

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