MAUDE Adverse Event Report: TRIMED, INC PEG GUIDE EXTENDER

Model Number	XTNDRGUIDE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2018, trimed was notified of a peg extender that was found to have started to rust.The rep reported that this feedback was not associated with a clinical event, and there was no patient involvement.This is the seventh complaint of this kind for this part.

• Brand Name: PEG GUIDE EXTENDER
• Common Device Name: PEG GUIDE EXTENDER
• Manufacturer (Section D): TRIMED, INC; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 7355989
• Report Number: 2031009-2018-00017
• Device Sequence Number: 16288921
• Product Code: LXH
• UDI-Device Identifier: 00842188112850
• UDI-Public: 00842188112850
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/28/2018

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: XTNDRGUIDE
• Device Catalogue Number: XTNDRGUIDE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1