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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 Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Customer reported that a pt pushed a zipper teeth loose on the left side panel.Customer also reported that a tooth on the left panel is missing on one section.Customer did not provide the date when the incident occurred but did provide that there was no pt injury.
 
Manufacturer Narrative
Evaluation of the product confirmed the reported issue: the left side window zipper is missing one element (tooth) on the zipper track.(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 CP 2 2664
MX   CP 22664
Manufacturer Contact
pam wampler, admin
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key3810657
MDR Text Key4386221
Report Number2020362-2014-00096
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 02/27/2014
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 Other
Device Model Number8070
Device Catalogue Number8070
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/06/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/27/2014
Initial Date FDA Received03/24/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2011
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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