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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIMED INC QUICK GUIDE, 1.8MM
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TRIMED INC QUICK GUIDE, 1.8MM Back to Search Results
Model Number GUIDEQ-1.8
Medical Device Problem Code Product Quality Problem (1506)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/09/2021
Type of Reportable Event Malfunction
Event or Problem Description
A trimed sales representative reported on (b)(6) 2021 that the guideq-1.8 from a wrist fixation set had "not for human use" laser marked on the bottom of the drill guide.He stated this device was found during a routine check of his tray and that he is unsure if the device had come in contact with a patient but doesn't believe this issue caused any additional patient harm or delay in surgery.
 
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Brand Name
QUICK GUIDE, 1.8MM
Common Device Name
QUICK GUIDE, 1.8MM
Manufacturer (Section D)
TRIMED INC
27533 avenue hopkins
santa clarita CA 91355
MDR Report Key12433457
Report Number2031009-2021-00004
Device Sequence Number11610965
Product Code LXH
UDI-Device Identifier00842188112898
UDI-Public00842188112898
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/07/2021
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 NumberGUIDEQ-1.8
Device Catalogue NumberGUIDEQ-1.8
Device Lot NumberBA19001
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/07/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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