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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; COMFORT SHORT 110/13 PCC
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SILHOUETTE® PARADIGM®; COMFORT SHORT 110/13 PCC Back to Search Results
Lot Number 5199568
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that in one of the infusion sets, the tube of the cannula side part, which was inserted under the skin came off.No further information available.
 
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Brand Name
SILHOUETTE® PARADIGM®
Common Device Name
COMFORT SHORT 110/13 PCC
MDR Report Key8635090
Report Number8021545-2019-00127
Device Sequence Number2073273
Product Code FPA
UDI-Device Identifier05705244009165
UDI-Public05705244009165
Combination Product (Y/N)N
PMA/510(K) Number
K162812
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date08/01/2020
Device Lot Number5199568
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/15/2018
Initial Report FDA Received Date05/23/2019
Patient Sequence Number1
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