MAUDE Adverse Event Report: MICROTEK DOMINICANA, S.A. PROBE DRAPE W/GEL; PROBE COVERS

Model Number	PC3787
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a procedure, a hole was discovered in the top of the ultrasound probe cover.This left the probe cover exposed.No patient complications have been reported as a result of this event.

• Brand Name: PROBE DRAPE W/GEL
• Common Device Name: PROBE COVERS
• Manufacturer (Section D): MICROTEK DOMINICANA, S.A.; las americas free zone park; km 22; santo domingo, 11606 ; DR 11606
• MDR Report Key: 9216011
• Report Number: 8043817-2019-40030
• Device Sequence Number: 16741198
• Product Code: KKX
• UDI-Device Identifier: 50748426046367
• UDI-Public: 50748426046367
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K882724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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 Model Number: PC3787
• Device Lot Number: D190499
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1