MAUDE Adverse Event Report: TRIMED, INC PEG EXTENDER

Model Number	PEG-XTNDR
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During visual review of material being sent to hospital, it was discovered that the spring on a peg-xtndr had corroded.The non-conforming part was returned to the distributor, at which point the distributor notified trimed of the complaint on (b)(6) 2017.This incident occurred in (b)(6).This type of malfunction for this part has an occurrence rate of (b)(4) based on sales since 2010.

• Brand Name: PEG EXTENDER
• Common Device Name: PEG EXTENDER
• Manufacturer (Section D): TRIMED, INC; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 7136679
• Report Number: 2031009-2017-00038
• Device Sequence Number: 927078
• Product Code: LXH
• UDI-Device Identifier: 00842188112867
• UDI-Public: 00842188112867
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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: No Information
• Device Model Number: PEG-XTNDR
• Device Catalogue Number: PEG-XTNDR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1