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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S UNKNOWN INFUSION SET

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UNOMEDICAL A/S UNKNOWN INFUSION SET Back to Search Results
Model Number UNKNOWN
Device Problem No Apparent Adverse Event (3189)
Patient Problem Coma (2417)
Event Date 01/14/2020
Event Type  Injury  
Manufacturer Narrative
No infusion set malfunction was reported for this event. An investigation has been performed based on the customer complaint description. No further investigation can be made before a lot number and brand name is available. If new information becomes available the complaint will be reopened and appropriate action will be taken.
 
Event Description
Unomedical reference number (b)(4). On (b)(6) 2020 a female diabetic patient on pump therapy was hospitalized due to high blood glucose of 1000 mg/dl. And ketoacidoses. The patient experienced a coma for 11 days. No information about treatment was reported. The patient was discharged after 11 days. No malfunction of the infusion set was reported. Infusion set brand name unknown. No further information available.
 
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Brand NameUNKNOWN INFUSION SET
Type of DeviceUNKNOWN INFUSION SET
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer (Section G)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key9749374
MDR Text Key182725847
Report Number3003442380-2020-00002
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/25/2020 Patient Sequence Number: 1
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