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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 2860; BED, FLOTATION THERAPY, POWERED
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STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 2860; BED, FLOTATION THERAPY, POWERED Back to Search Results
Catalog Number 2860000000
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Pressure Sores (2326)
Event Date 07/13/2017
Event Type  Injury  
Event Description
It was reported the patient's skin broke down on the mattress.The wound care specialist reports the mattress may have contributed to a scapular wound.It was not reported if medical intervention was administered.
 
Manufacturer Narrative
It was it was identified that the customer had assumed that isoflex lal (a gel support surface) was an air mattress rather than a gel mattress.It was identified that an air mattress may be better suited for this account's needs.The customer's isoflex lal units were replaced with isoair units (an air support surface).No device malfunction alleged.
 
Event Description
It was reported the patient's skin broke down on the mattress.The wound care specialist reports the mattress may have contributed to a scapular wound.It was not reported if medical intervention was administered.
 
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Brand Name
ISOFLEX LAL 2860
Type of Device
BED, FLOTATION THERAPY, 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
mary klaver
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6801635
MDR Text Key82944503
Report Number0001831750-2017-00340
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/12/2017
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 Number2860000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/20/2017
Initial Date FDA Received08/17/2017
Supplement Dates Manufacturer Received07/20/2017
Supplement Dates FDA Received12/12/2017
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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