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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY PRODUCTS LLC MITTS - NO FINGER SEPARATORS RESTRAINT, PROTECTIVE

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POSEY PRODUCTS LLC MITTS - NO FINGER SEPARATORS RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2814
Device Problem Material Integrity Problem (2978)
Patient Problem Skin Tears (2516)
Event Type  Injury  
Manufacturer Narrative
Customer confirmed product had been discarded. Therefore, this event is reported solely on the information provided by the customer. A review of the historical database did not find any other complaints related to the use of this material in our products 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 warning 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 the failure mode will assessed, documented and acted upon as warrant. Manufacturer reference file #(b)(4). Product will not be returning.
 
Event Description
Customer reported the nurses are complaining of patient skin issues that they believe may be related to the material change that was made to the sheepskin type fur at the wrist. Additional information received on 2019/02/21 stated the customer was prone to skin breakdown and developed a skin tear during use of the mitt. Blood was found on the edges of the mitt and the patient's wound was dressed by the nurse. The date the issue was discovered is unknown.
 
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Brand NameMITTS - NO FINGER SEPARATORS
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCTS LLC
5635 peck rd
arcadia CA 91006
Manufacturer Contact
william hincy
posey company
5635 peck road
arcadia, CA 91006
6264433143
MDR Report Key8436521
MDR Text Key139329322
Report Number2020362-2019-00044
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 02/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2814
Device Catalogue Number2814
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/21/2019
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

Patient Treatment Data
Date Received: 03/20/2019 Patient Sequence Number: 1
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