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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY COMPANY SLEEVED JACKET RESTRAINT, PROTECTIVE

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POSEY COMPANY SLEEVED JACKET RESTRAINT, PROTECTIVE Back to Search Results
Model Number 3350
Device Problems Material Separation (1562); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2017
Event Type  malfunction  
Manufacturer Narrative
Age/date of birth, weight: ni. Conclusions: evaluation of the returned product confirmed the tear down the middle from the collar stopping at the top of the sewn strap. Further inspection of the yellow binding for the collar displayed stitching holes on both sides of the binding material suggesting that the collar was properly sewn to the flannel fabric. There were no rips or tears found along the edges of the flannel fabric where the yellow binding is sewn and no threads were found on either the yellow binding or flannel material to inspect. There were no injuries reported as the product was taken out of use at the time of occurrence. In addition, the age of the product and determination if proper laundering was followed could not be determined due to the wash label being removed. A review of the complaint database was performed and did not reveal any similar events. At this time there is no evidence that a manufacturing non-conformity contributed to the reported event, 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. The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. The ifu states "before use, check device for damage. Discard device if you have any questions about patient safety. " (b)(4).
 
Event Description
Customer reported the vest ripped through the middle while a nurse was putting it on a patient. There were no patient injuries reported.
 
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Brand NameSLEEVED JACKET
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 Key6568073
MDR Text Key75327151
Report Number2020362-2017-00016
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963442
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 04/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3350
Device Catalogue Number3350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
Was Device Evaluated by Manufacturer? Yes
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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