MAUDE Adverse Event Report: SILHOUETTE PARADIGM; UNO COMFORT SHORT 110/13 PCC MINI

Model Number MMT-382

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.On (b)(6) 2022, it was reported that while the patient was watching television, the infusion set's tubing detached from the quick release at the site and the site was wet.The site location was right side of patient's abdomen and the pump was located on the right side.Moreover, the infusion had been used for three days.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.No further information available.

• Brand Name: SILHOUETTE PARADIGM
• Type of Device: UNO COMFORT SHORT 110/13 PCC MINI
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14081226
• MDR Text Key: 289521380
• Report Number: 8021545-2022-00135
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244009165
• UDI-Public: 05705244009165
• Combination Product (y/n): Y
• PMA/PMN Number: K162812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2022

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
• Device Expiration Date: 07/01/2022
• Device Model Number: MMT-382
• Device Lot Number: 5289406
• Initial Date Manufacturer Received: 04/02/2022
• Initial Date FDA Received: 04/12/2022
• Patient Sequence Number: 1