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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 Misassembled (1398)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Evaluation results: evaluation of the returned device found that the male buckle components at the bed connecting straps were installed backwards, causing the bed connecting straps to slip when pulled. The issue has been addressed internally via corrective action. 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).
 
Event Description
Customer reported the teeth appear to be correct, but the strap is not holding. 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 91006
Manufacturer Contact
william hincy
5635 peck road
arcadia, CA 91006
6264433143
MDR Report Key8498259
MDR Text Key142218205
Report Number2020362-2019-00116
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 03/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2532
Device Catalogue Number2532
Device Lot Number9021T147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2019
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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