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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 2800-000-000 35X84 P NYLA; COVER, MATTRESS (MEDICAL PURPOSES)
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STRYKER MEDICAL-KALAMAZOO 2800-000-000 35X84 P NYLA; COVER, MATTRESS (MEDICAL PURPOSES) Back to Search Results
Catalog Number IMR000000
Device Problem Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2014
Event Type  malfunction  
Event Description
It was reported via repair work order that the top cover had fluid ingress.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via repair work order that the top cover had fluid ingress.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
2800-000-000 35X84 P NYLA
Type of Device
COVER, MATTRESS (MEDICAL PURPOSES)
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
pravin betala
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3622730
MDR Text Key4256019
Report Number0001831750-2014-01186
Device Sequence Number1
Product Code FMW
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 01/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberIMR000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received01/14/2014
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
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