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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S COMFORT SHORT

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UNOMEDICAL A/S COMFORT SHORT Back to Search Results
Model Number 100-240-01
Device Problem No Apparent Adverse Event (3189)
Patient Problem Death (1802)
Event Date 02/05/2018
Event Type  Death  
Manufacturer Narrative
On 18-apr-2018: used infusion set received for investigation on 17-apr-2018. These will be tested and follow up mdr report with test result will be submitted thereafter.
 
Event Description
Unomedical reference number: (b)(4). Reporter (hcp) stated police were called for a while being check. Police found patient deceased on his bed and he was deceased for about 1-2 days. Reporter stated the male diabetic patient was wearing the animas pump at the time of death around his waist. Reporter stated patient was brought to the medical examiner on (b)(6) 2018. Reporter stated the autopsy was done the (b)(6) 2018. Police reported that it was hot in the room. Blood glucose level unknown at time of event. Reporter felt death occurred due to use of the product. No malfunction has been reported. No further information available.
 
Manufacturer Narrative
On 16-may-2018: a visual inspection and a test for flow and leak were performed on the returned used device (1 set). Flow and leak test results were within specifications. On 18-apr-2018: used infusion set received for investigation on 17-apr-2018. These will be tested and follow up mdr report with test result will be submitted thereafter.
 
Event Description
(b)(4). Reporter (hcp) stated police were called for a while being check. Police found patient deceased on his bed and he was deceased for about 1-2 days. Reporter stated the male diabetic patient was wearing the animas pump at the time of death around his waist. Reporter stated patient was brought to the medical examiner on (b)(6) 2018. Reporter stated the autopsy was done (b)(6) 2018. Police reported that it was hot in the room. Blood glucose level unknown at time of event. Reporter felt death occurred due to use of the product. No malfunction has been reported. No further information available.
 
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Brand NameCOMFORT SHORT
Type of DeviceCOMFORT SHORT
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
558167000
MDR Report Key7439149
MDR Text Key105750231
Report Number8021545-2018-00005
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number100-240-01
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/18/2018 Patient Sequence Number: 1
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