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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILHOUETTE PARADIGM UNO COMFORT SHORT 60/13 SC1 MIN

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SILHOUETTE PARADIGM UNO COMFORT SHORT 60/13 SC1 MIN Back to Search Results
Model Number MMT-381A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Hyperglycemia (1905)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. On (b)(6) 2021, it was reported that the patient's infusion set's tubing came apart at the site location. The site location was patient's right thigh, and the pump was at right side of patient's waist. Moreover, the infusion had been used for the first day. Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity. There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body. Currently, patient's blood glucose level was 286 mg/dl. No further information available.
 
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Brand NameSILHOUETTE PARADIGM
Type of DeviceUNO COMFORT SHORT 60/13 SC1 MIN
MDR Report Key12597270
MDR Text Key276461809
Report Number8021545-2021-00155
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
Type of Report Initial
Report Date 10/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-381A
Device Lot Number5350765
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
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?
Type of Device Usage

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