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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIZEWISE WORLDWIDE SIZEWISE PSYCH HOSPITAL BED BED, MANUAL

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SIZEWISE WORLDWIDE SIZEWISE PSYCH HOSPITAL BED BED, MANUAL Back to Search Results
Model Number HOSPITAL PSYCH BED
Device Problem Device Slipped (1584)
Patient Problem No Information (3190)
Event Date 05/03/2018
Event Type  Injury  
Event Description
Safety screws on sizewise psych hospital bed were loose. Pt was able to remove 2 screws from interior head siderail. The screws were swallowed by the patient which required surgery for removal. All beds were checked. Several beds found to have loose screws. All screws on all sizewise psych beds were attached with adhesive and tightened to bed.
 
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Brand NameSIZEWISE PSYCH HOSPITAL BED
Type of DeviceBED, MANUAL
Manufacturer (Section D)
SIZEWISE WORLDWIDE
8601 monrovia st.
lenexa KS 66215
MDR Report Key7553258
MDR Text Key109679907
Report NumberMW5077517
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHOSPITAL PSYCH BED
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/29/2018 Patient Sequence Number: 1
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