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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KCI USA, INC. SNAP NEGATIVE PRESSURE WOUND THERAPY NON-POWERED SUCTION APPARATUS

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KCI USA, INC. SNAP NEGATIVE PRESSURE WOUND THERAPY NON-POWERED SUCTION APPARATUS Back to Search Results
Catalog Number SKTF15X15
Device Problem Material Discolored (1170)
Patient Problem Insufficient Information (4580)
Event Date 05/19/2021
Event Type  malfunction  
Event Description
(b)(6): snap therapy system dressing 15 x 15 cm was received with discolored foam. Foam is blue, by standard, but appeared to have a green edge. All packages within the recent shipment contained foam that was discolored green along the edge. All 10 boxes of product were inspected and discovered to have similar defect. Product was not applied to the patient. Product rep was contacted about defective concerns. Product is being replaced at no charge, with product returned to distributor/manufacturer through product rep.
 
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Brand NameSNAP
Type of DeviceNEGATIVE PRESSURE WOUND THERAPY NON-POWERED SUCTION APPARATUS
Manufacturer (Section D)
KCI USA, INC.
12930 ih 10 west
san antonio TX 78249
MDR Report Key11991159
MDR Text Key255977927
Report Number11991159
Device Sequence Number1
Product Code OKO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSKTF15X15
Device Lot Number8477883V002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/24/2021
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer06/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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