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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 84IN W OPTION CVR; MATTRESS, FLOATATION THERAPY, NON-POWERED

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STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 84IN W OPTION CVR; MATTRESS, FLOATATION THERAPY, NON-POWERED Back to Search Results
Model Number 2860
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem Pain (1994)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was not evaluated, as during communication/interviews with a stryker quality assurance engineer, the customer stated there was no defect/malfunction with the product.There was no remedial action taken.  this device is not labeled for single use.
 
Event Description
This report summarizes 1 malfunction event, where it was reported that the mattress was heavy and/or hard to move.There was 1 instance with patient involvement; where a user experienced pain.
 
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Brand Name
ISOFLEX LAL 84IN W OPTION CVR
Type of Device
MATTRESS, FLOATATION THERAPY, NON-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
kaitlyn matheny
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key11715486
MDR Text Key250426148
Report Number0001831750-2021-00787
Device Sequence Number1
Product Code IKY
UDI-Device Identifier07613327278507
UDI-Public07613327278507
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number2860
Device Catalogue Number2860000019
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/01/2021
Initial Date FDA Received04/23/2021
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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