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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - N; BED, PATIENT ROTATION, POWERED

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STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - N; BED, PATIENT ROTATION, POWERED Back to Search Results
Catalog Number 2971000000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 06/23/2016
Event Type  Injury  
Manufacturer Narrative
No defect reported that would be cause for an evaluation.
 
Event Description
It was alleged that an employee lifted up a mattress with one hand and was cleaning underneath it with the other hand, but then dropped the mattress on her hand.This allegedly caused an injury that kept her out of work for several weeks.No patient involvement was reported.
 
Manufacturer Narrative
The issue was resolved for the customer by the sales rep discussing proper cleaning practices with the account (which requires two staff members to maneuver the mattress per the user manual) and confirming that nothing further was required at this time.
 
Event Description
It was alleged that an employee lifted up a mattress with one hand and was cleaning underneath it with the other hand, but then dropped the mattress on her hand.This allegedly caused an injury that kept her out of work for several weeks.No medical intervention and no patient involvement was reported.
 
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Brand Name
ISOLIBRIUM SUPPORT SURFACE - N
Type of Device
BED, PATIENT ROTATION, POWERED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
chanda burghard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key5866842
MDR Text Key51814345
Report Number0001831750-2016-00253
Device Sequence Number1
Product Code IKZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/13/2016
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? No
Device Operator No Information
Device Catalogue Number2971000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/13/2016
Initial Date FDA Received08/10/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/21/2016
Was Device Evaluated by Manufacturer? No
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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