• 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 QUICK-SET PARADIGM INFUSION SET

  • 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 QUICK-SET PARADIGM INFUSION SET Back to Search Results
Model Number MMT-399
Device Problem No Apparent Adverse Event (3189)
Patient Problem Coma (2417)
Event Type  Injury  
Manufacturer Narrative
On 07-jul-2017: this case has been closed due to missing information. No relevant testing could be performed. Since the lot number is unknown, no batch record review or testing of retained samples could be performed. If the lot number becomes available, the case will be re-opened and appropriate actions will be taken.
 
Event Description
Unomedical reference number: (b)(4). In (b)(6) 2016 a male diabetic patient experienced hypoglycemic incident (not picked up by the cgm), went unconscious and his car set on fire. The patient was flighted to a burn unit where he was hospitalized for 3 weeks. The patient was wearing pump at time of incident. No blood glucose was reported. No malfunction with infusion set reported. No further information available. The reporter is the patients legal representative (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameQUICK-SET PARADIGM INFUSION SET
Type of DeviceQUICK-SET PARADIGM INFUSION SET
Manufacturer (Section G)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
548167000
MDR Report Key6692267
MDR Text Key79229598
Report Number3003442380-2017-00008
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 07/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-399
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/07/2017 Patient Sequence Number: 1
-
-