MAUDE Adverse Event Report: MICROTEK MEDICAL INC. ECOALB -; SLUSH + WARMER DISC-DRAPE, 66" X 44"

Model Number ORS-320

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/19/2020

Event Type  malfunction  

Event Description

It was reported that a whole was found near the plate of the warming drape.The cut was found prior to use on any patient.

• Brand Name: ECOALB -
• Type of Device: SLUSH + WARMER DISC-DRAPE, 66" X 44"
• Manufacturer (Section D): MICROTEK MEDICAL INC.; 602 lehmberg road; columbs, ms
• Manufacturer (Section G): MICROTEK DOMINICANA S.A; las americas free zone park; km 22, autopista las americas; santo domingo, santo domingo 11606 ; DR 11606
• Manufacturer Contact: steven deline ; one ecolab place; st. paul, mn ; 2503477
• MDR Report Key: 9867988
• MDR Text Key: 202533462
• Report Number: 1043582-2020-00002
• Device Sequence Number: 1
• Product Code: LHC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORS-320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Manufacturer Received: 02/29/2920
• Initial Date FDA Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2019
• 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