• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KCI USA, INC. ABTHERA¿ SENSAT.R.A.C.¿ MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameABTHERA¿ SENSAT.R.A.C.¿
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
KCI USA, INC.
12930 ih 10 west
san antonio TX 78249
MDR Report Key9847327
MDR Text Key183894822
Report Number9847327
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received03/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM8275026/5
Device Catalogue NumberM8275026/5
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/31/2020
Event Location No Information
Date Report to Manufacturer03/18/2020
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

-
-