MAUDE Adverse Event Report: TRICE MEDICAL INC. MI-EYE 2 CAMERA; ARTHROSCOPE

Catalog Number	T200-095
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a marketing demo procedure, the pt developed an infected knee and was admitted to the hospital.At this point, the pt's knee was washed out with antibiotics.Fda safety report id# (b)(4).

• Brand Name: MI-EYE 2 CAMERA
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): TRICE MEDICAL INC. ; malvern PA 19355
• MDR Report Key: 8717323
• Report Number: MW5087486
• Device Sequence Number: 2220924
• Product Code: HRX
• UDI-Device Identifier: 00861578000331
• UDI-Public: 00861578000331
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: T200-095
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention