MAUDE Adverse Event Report: LIFE INSTRUMENT CORP. LIFE INSTRUMENT CO CURETTE; CURETTE, SURGICAL, GENERAL USE

Lot Number 712-1001-2 06-12M

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2020

Event Type  malfunction  

Event Description

Surgeon using in proper fashion, broken handle.Fda safety report id # (b)(4).

• Brand Name: LIFE INSTRUMENT CO CURETTE
• Type of Device: CURETTE, SURGICAL, GENERAL USE
• Manufacturer (Section D): LIFE INSTRUMENT CORP.
• MDR Report Key: 11207403
• MDR Text Key: 228442381
• Report Number: MW5098907
• Device Sequence Number: 1
• Product Code: FZS
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 712-1001-2 06-12M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR