MAUDE Adverse Event Report: TSI / TEDAN SURGICAL INNOVATIONS, INC. TRIMLINE CURETTE; CURETTE, SURGICAL, GENERAL USE

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/09/2021

Event Type  Injury  

Event Description

Tip of curette broke off during use.Fda safety report id# (b)(4).

• Brand Name: TRIMLINE CURETTE
• Type of Device: CURETTE, SURGICAL, GENERAL USE
• Manufacturer (Section D): TSI / TEDAN SURGICAL INNOVATIONS, INC.
• MDR Report Key: 12008115
• MDR Text Key: 256717600
• Report Number: MW5101905
• Device Sequence Number: 1
• Product Code: FZS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR