MAUDE Adverse Event Report: ECOLAB/MICROTEK MEDICAL INC. MICROTEK; ABSORBANT TABLE COVER

Model Number ABTSLSF

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2022

Event Type  malfunction  

Event Description

It was reported that the patient slid while in the trendelenberg postion.No patient infection, injury, or complications were reported.

• Brand Name: MICROTEK
• Type of Device: ABSORBANT TABLE COVER
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL INC.; 1 ecolab pl; st. paul MN 55102
• Manufacturer (Section G): GLOBAL RESOURCES INC.(GRI); 1805 honggao rd; xiuzhou industry zone; jiaxing, zhejiang 31403 1; CH 314031
• Manufacturer Contact: emily scott ; 1 ecolab pl; st. paul, MN 55102
• MDR Report Key: 14137024
• MDR Text Key: 295346569
• Report Number: 1043582-2022-00002
• Device Sequence Number: 1
• Product Code: KME
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABTSLSF
• Device Lot Number: 211005V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1