MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; COMFORT SHORT 80/13 PCC

Model Number	MMT-383
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
(b)(4).Event occurred in the united states.It was reported that when the patient woke up, he noticed that his infusion set's tubing had disconnected at the site while sleeping.The site location was his abdomen and thigh and the pump was located 3 inches away from the site.The infusion had been used for one night and they were stored in the home.They were unsure of any stress or pull on the tubing and was the pump was not dropped with the set connected to his body.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: COMFORT SHORT 80/13 PCC
• MDR Report Key: 9971081
• Report Number: 8021545-2020-00104
• Device Sequence Number: 666358
• Product Code: FPA
• UDI-Device Identifier: 05705244008892
• UDI-Public: 05705244008892
• Combination Product (Y/N): N
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• 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 Model Number: MMT-383
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 04/17/2020
• Patient Sequence Number: 1