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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS MATTRESS, RESOLUTION 36 X 80 X 6 9153647363; MATTRESS, FLOTATION THERAPY, NON-POWERED

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INVACARE FLORIDA OPERATIONS MATTRESS, RESOLUTION 36 X 80 X 6 9153647363; MATTRESS, FLOTATION THERAPY, NON-POWERED Back to Search Results
Model Number 5310IVC
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Discomfort (2330)
Event Type  malfunction  
Event Description
(b)(4).End user states the mattress springs are starting to poke her and the mattress is uncomfortable.
 
Manufacturer Narrative
Should additional information become available a supplemental record will be filed.
 
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Brand Name
MATTRESS, RESOLUTION 36 X 80 X 6 9153647363
Type of Device
MATTRESS, FLOTATION THERAPY, NON-POWERED
Manufacturer (Section D)
INVACARE FLORIDA OPERATIONS
2101 east lake mary blvd
sanford FL 32773
Manufacturer (Section G)
INVACARE FLORIDA OPERATIONS
2101 east lake mary blvd
sanford FL 32773
Manufacturer Contact
kevin guyton
1200 taylor street
elyria, OH 44036
MDR Report Key4837347
MDR Text Key19745451
Report Number1031452-2015-14288
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 05/20/2015
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 Lay User/Patient
Device Model Number5310IVC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/20/2015
Initial Date FDA Received06/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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