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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO MERIT CUSTOM KIT
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MERIT MEDICAL SYSTEMS MEXICO MERIT CUSTOM KIT Back to Search Results
Catalog Number K04-MZ3921B
Medical Device Problem Code Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 07/26/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Corrective actions are in process.
 
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event or Problem Description
The distributor alleged a defect in the packaging was found during their initial inspection of received product.The device was not sent to a user facility.
 
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Brand Name
MERIT CUSTOM KIT
Common Device Name
CUSTOM KIT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS MEXICO
8830 siempre viva rd #100
san diego CA 92154
MDR Report Key9469416
Report Number3011642792-2019-00027
Device Sequence Number3483105
Product Code OJA
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/13/2019
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 Expiration Date12/31/2021
Device Catalogue NumberK04-MZ3921B
Device Lot NumberI1488371
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2019
Initial Date Received by Manufacturer 11/13/2019
Supplement Date Received by Manufacturer02/10/2020
Initial Report FDA Received Date12/13/2019
Supplement Report FDA Received Date02/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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