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

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.

• Brand Name: SNAP
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY NON-POWERED SUCTION APPARATUS
• Manufacturer (Section D): KCI USA, INC.; 12930 ih 10 west; san antonio TX 78249
• MDR Report Key: 11991159
• MDR Text Key: 255977927
• Report Number: 11991159
• Device Sequence Number: 1
• Product Code: OKO
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SKTF15X15
• Device Lot Number: 8477883V002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2021
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1