MAUDE Adverse Event Report: TRIMED, INC. DENTAL PICK

Model Number	PICK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Trimed received the following report on (b)(6) 2018 from trimed sales member, steve slaughter located in the united states, regarding the dental pick (pick): during a hardware removal operation the tip of the pick broke off, the tip was recovered and this incident did not cause any further harm to the patient.This is the first time this type of malfunction has been reported to trimed.

• Brand Name: DENTAL PICK
• Common Device Name: DENTAL PICK
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 7648882
• Report Number: 2031009-2018-00035
• Device Sequence Number: 18862953
• Product Code: LXH
• UDI-Device Identifier: 00842188110108
• UDI-Public: 00842188110108
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2018

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: PICK
• Device Catalogue Number: PICK
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1