MAUDE Adverse Event Report: KCI USA, INC. ABTHERA¿ SENSAT.R.A.C.¿; MESH, SURGICAL, POLYMERIC

Model Number M8275026/5

Device Problem Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2019

Event Type  malfunction  

Event Description

High potential for retained surgical item when using device.When sizing the visceral protective layer by cutting, the foam in the dressing has the potential to fall out and into the patient.

• Brand Name: ABTHERA¿ SENSAT.R.A.C.¿
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): KCI USA, INC.; 12930 ih 10 west; san antonio TX 78249
• MDR Report Key: 9847327
• MDR Text Key: 183894822
• Report Number: 9847327
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M8275026/5
• Device Catalogue Number: M8275026/5
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2020
• Date Report to Manufacturer: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1