MAUDE Adverse Event Report: MICROTEK MEDICAL, INC MICROTEK GENERAL PURPOSE PROBE COVER; DRAPE, SURGICAL, EXEMPT

Model Number	1
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Probe cover had hole in seam.Fda safety report id# (b)(4).

• Brand Name: MICROTEK GENERAL PURPOSE PROBE COVER
• Common Device Name: DRAPE, SURGICAL, EXEMPT
• Manufacturer (Section D): MICROTEK MEDICAL, INC; columbus MS 39702
• MDR Report Key: 15233514
• Report Number: MW5111479
• Device Sequence Number: 15133611
• Product Code: PUI
• UDI-Device Identifier: 00748426120628
• UDI-Public: (01)00748426120628(17)250527(10)
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2025
• Device Model Number: 1
• Device Catalogue Number: PC1290
• Device Lot Number: D220671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown