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

Lot Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Unomedical reference number: (b)(4).Event occurred in the united states.The patient reported that one of the infusions set broke off in the patient's body during use and had to operate to get it removed from the body because it was floating around in the body.The set insertion location was at the right side of abdomen, below breast, between breast and waistline.The infusion had been in use for about 6 months.She had pain at the site since then, so she went to her health care professional and he did an x-ray and found the cannula was still inside her body.She inserted the set it stung after removing introducer needle, but site seemed okay but when she went to remove the set 3 days later it bleeds.At the time of this report, she was waiting for her surgeon to call back with a surgery date to have cannula surgically removed.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Type of Device: COMFORT SHORT 110/13 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8538581
• MDR Text Key: 142735072
• Report Number: 8021545-2019-00129
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244009165
• UDI-Public: 05705244009165
• Combination Product (y/n): N
• PMA/PMN Number: K162812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/03/2018
• Type of Device Usage: N
• Patient Sequence Number: 1