Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC EXTENDED; UNO EWIS BLUE 80/9 HCAP 3-PK INT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UNOMEDICAL A/S MEDTRONIC EXTENDED; UNO EWIS BLUE 80/9 HCAP 3-PK INT Back to Search Results
Model Number MMT-442AH
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/28/2024
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that the patient faced an infusion set cannula was crimped on (b)(6) 2024.No further information was available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MEDTRONIC EXTENDED
Common Device Name
UNO EWIS BLUE 80/9 HCAP 3-PK INT
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA  4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key19946222
Report Number8021545-2024-03219
Device Sequence Number18042969
Product Code FPA
UDI-Device Identifier05705244023314
UDI-Public05705244023314
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)N
Reporter Type Manufacturer
Report Source Distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/09/2024
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 Lay User/Patient
Device Expiration Date01/01/2026
Device Model NumberMMT-442AH
Device Lot Number6005411
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/09/2024
Initial Report FDA Received Date08/08/2024
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured02/13/2024
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
Patient SexUnknown
-
-