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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 Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Customer reported to tha left side panel slider nd the retaining box which was found during set up.Customer did not provided a date when discovered.No pt incident or injury was reported.
 
Manufacturer Narrative
Results - eval of the returned product found on the left side window pt access zipper slider body is open.Right side window top rail nylon is frayed.Head panel both legs have a 1 inch tear.(b)(4).
 
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Brand Name
POSEY BED
Manufacturer (Section D)
J. T. POSEY CO.
arcadia CA
Manufacturer (Section G)
J. T. POSEY CO.
de r.l. de c.v. ave. ferrocarril
no. 16901
bodega tijuana, c.p. 2266 4
MX   22664
Manufacturer Contact
pam wampler, administrator
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key3826855
MDR Text Key4399869
Report Number2020362-2014-00069
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 Health Professional,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer02/18/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/19/2014
Initial Date FDA Received02/28/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2009
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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