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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 Moisture Damage (1405)
Patient Problem Sweating (2444)
Event Type  Injury  
Manufacturer Narrative
This report is based solely on the customer's reported issue. The device was discarded by the user and is not available for evaluation. Historical data did not reveal any similar instances of moisture (sweat) causing skit irritation. 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. Manufacturer reference file # (b)(4). Product discarded.
 
Event Description
Customer reported the limb holder gets wet when the patient sweats. The wet foam causes skin problems due to the wetness. The restraint has been disposed of so the customer is unable to return for evaluation. The date the issue was discovered was not reported.
 
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Brand NameFOAM LIMB HOLDER
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY COMPANY
5635 peck road
arcadia CA 91006
Manufacturer Contact
william hincy
posey company
5635 peck road
arcadia, CA 91006
6264433143
MDR Report Key6553118
MDR Text Key74698019
Report Number2020362-2017-00018
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
Reporter Occupation
Type of Report Initial
Report Date 04/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2017
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

Patient Treatment Data
Date Received: 05/08/2017 Patient Sequence Number: 1
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