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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSET GUARD; UNO EWIS BLUE 60/9 HCAP 3-PK INT
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INSET GUARD; UNO EWIS BLUE 60/9 HCAP 3-PK INT Back to Search Results
Model Number MMT-441AH
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/18/2026
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Request was performed for additional information including lot number; however, lot number was not provided.A complaint investigation was initiated under complaint investigation.Unfortunately, no specific lot number was identified, which limits the ability to trace or analyze a particular item.Investigation in progress.
 
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that patient faced an infusion set tape not sticking event on (b)(6) 2026.Patient stated that it didn't have that much adhesive so it didn't stick.No further information available.
 
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Brand Name
INSET GUARD
Common Device Name
UNO EWIS BLUE 60/9 HCAP 3-PK INT
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key24624583
Report Number8021545-2026-01317
Device Sequence Number21045845
Product Code FPA
UDI-Device Identifier05705244023284
UDI-Public05705244023284
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K210544
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/21/2026
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
Device Model NumberMMT-441AH
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/21/2026
Initial Report FDA Received Date03/17/2026
Patient Sequence Number1
Patient SexUnknown
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