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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCARE CARE SLING WITH HEAD SUPPORT
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MEDCARE CARE SLING WITH HEAD SUPPORT Back to Search Results
Device Problems Break (1069); Degraded (1153)
Patient Problem Head Injury (1879)
Event Type  malfunction  
Event Description
Sling straps snapping causing a patient fall to the floor.
 
Manufacturer Narrative
This incident was reported by the patient's family member (daughter) who witnessed the event.The daughter stated that the sling straps snapped causing her (mother) to fall to the floor.She hit her spine and head, but no additional information could be obtained relative to the extent of her injuries.Pictures were taken of the broken sling and were forwarded to us.The broken sling was disposed of by the care facility, therefore our investigation was limited to the pictures.No date of manufacture or serial number could be found on the label which indicates the sling was several years old (serial numbers, which include a date of manufacture, have been included on all sling labels since 2012).This assessment was substantiated by the faded color and rippled texture of the sling straps.This also indicates the sling had been laundered extensively.
 
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Brand Name
CARE SLING WITH HEAD SUPPORT
Type of Device
NA
Manufacturer (Section D)
MEDCARE
burnsville MN 55337
Manufacturer Contact
steve kilburn
10888 metro ct
maryland heights, MO 63043-0000
3142198614
MDR Report Key4863269
MDR Text Key5808903
Report Number3007802293-2015-00017
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/22/2015
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
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