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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J. T. POSEY CO. POSEY BED
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J. T. POSEY CO. POSEY BED Back to Search Results
Model Number 8070
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Customer reported a broken zipper in addition to teeth not aligning when secured close.Issue was discovered while in use but customer did not provide a date when it was discovered.No patient incident or injury was reported.
 
Manufacturer Narrative
Results - evaluation of the returned product confirmed that the zipper on the left window is separating when closed due to an open slider.No other damages were found.(b)(4).
 
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Brand Name
POSEY BED
Manufacturer (Section D)
J. T. POSEY CO.
arcadia CA
Manufacturer (Section G)
POSEY S. DE. RL DE CV
ave ferrocarril no. 16901 bodega 64
colonia rio tijuana 3ra etapa
tijuana 2266 4
MX   22664
Manufacturer Contact
roxana koussa
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key3998283
MDR Text Key4823491
Report Number2020362-2014-00231
Device Sequence Number1
Product Code OYS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103817
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8070
Device Catalogue Number8070
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/16/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received06/02/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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