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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VARISOFT UNO COMFORT SHORT 60/13 TCAP 10PK INT

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VARISOFT UNO COMFORT SHORT 60/13 TCAP 10PK INT Back to Search Results
Model Number 1002827
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states it was reported that on (b)(6) 2021, the patient's infusion set's tubing detached/broken at site connector prior to insertion. Further, they replaced the infusion set and insulin was resumed successfully. No further information available.
 
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Brand NameVARISOFT
Type of DeviceUNO COMFORT SHORT 60/13 TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key12883396
MDR Text Key281342459
Report Number8021545-2021-00173
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K162812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 11/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1002827
Device Lot Number5322017
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided

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