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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARROLL HEALTHCARE CS BED 9153650455; BED, AC-POWERED ADJUSTABLE HOSPITAL
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CARROLL HEALTHCARE CS BED 9153650455; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number IHCS7
Device Problems Component Missing (2306); Scratched Material (3020)
Patient Problem Injury (2348)
Event Type  malfunction  
Event Description
Customer alleged that the resident was scratched pretty bad from the rail due to no end cap being on the rail.Customer alleged that the resident had received stitches on her leg between the knee and ankle.
 
Event Description
Customer alleged that the resident was scratched pretty bad from the rail due to no end cap being on the rail.Customer alleged that the resident had received stitches on her leg between the knee and ankle.
 
Manufacturer Narrative
(b)(4) - should additional information become available for the patient, a supplemental record will be filed.
 
Manufacturer Narrative
(b)(4) - per the expanded evaluation, the bed rail had a sharp bur on one of the end tubes where the end cap was missing.
 
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Brand Name
CS BED 9153650455
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
CARROLL HEALTHCARE
994 hargrieve rd
london, on N6E 1P5
CA  N6E 1P5
Manufacturer (Section G)
CARROLL HEALTHCARE
994 hargrieve rd
london, on N6E 1P5
CA   N6E 1P5
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key4759609
MDR Text Key5781153
Report Number3003433498-2015-00069
Device Sequence Number1
Product Code FNL
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 Patient
Type of Report Initial,Followup
Report Date 06/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIHCS7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/04/2015
Initial Date FDA Received05/08/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/15/2015
Was Device Evaluated by Manufacturer? Yes
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) Required Intervention;
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