MAUDE Adverse Event Report: ECOLAB/MICROTEK MEDICAL INC MICROTEK; MINI C-ARM DRAPE FOR OEC 6800

Model Number	C9-108M
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the mini c-arm drapes are ripping/tearing at the seams while the scrub tech is draping them.Doctor states "this is not the first time this has happened with these drapes".No patient injury, infections or complications were reported.

• Brand Name: MICROTEK
• Common Device Name: MINI C-ARM DRAPE FOR OEC 6800
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL INC; 1 ecolab place; st. paul MN 55102
• Manufacturer (Section G): MICROTEK DOMINICANA S.A; zona franca no.2; la romana, la romana ; DR
• Manufacturer Contact: yarina montas ; 1 ecolab place; st. paul, MN 55102
• MDR Report Key: 19730996
• Report Number: 8043817-2024-00014
• Device Sequence Number: 15522409
• Product Code: PUI
• UDI-Device Identifier: 00748426066414
• UDI-Public: 00748426066414
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

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 Expiration Date: 04/01/2026
• Device Model Number: C9-108M
• Device Lot Number: 2153LRB500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown