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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 2860; MATTRESS, FLOTATION THERAPY, NON-POWERED

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STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 2860; MATTRESS, FLOTATION THERAPY, NON-POWERED Back to Search Results
Catalog Number 2860000000
Device Problem Material Too Soft/Flexible (4007)
Patient Problem Pressure Sores (2326)
Event Date 05/13/2020
Event Type  Injury  
Event Description
It was reported a patient developed bed sores while using the mattress.No information has been provided regarding the severity or treatment of the bed sores.Attempts have been made to reach the customer for more information; however, the customer has not responded to these attempts.
 
Manufacturer Narrative
It was originally reported that the treatment and severity of injury to the patient was unknown.Additional information has been provided by the user facility and b5 has been updated accordingly.
 
Event Description
It was reported a patient developed bed sores while using the mattress.The user facility was unable to determine the severity of the injury but were able to report a wound vac was used for treatment.
 
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Brand Name
ISOFLEX LAL 2860
Type of Device
MATTRESS, FLOTATION THERAPY, NON-POWERED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10139603
MDR Text Key194768222
Report Number0001831750-2020-00632
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/22/2020
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
Initial Date Manufacturer Received 05/13/2020
Initial Date FDA Received06/10/2020
Supplement Dates Manufacturer Received05/13/2020
Supplement Dates FDA Received09/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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