MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE PARADIGM; COMFORT SHORT

Model Number MMT-381

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 10/04/2017

Event Type  Death  

Manufacturer Narrative

Update 01/04/2018.Unomedical is still pending information about this event, therefore no testing has been performed at this time.A follow-up report vill be sent no later than 02/01/2018.

Event Description

(b)(4).(b)(6).Via an email from (b)(6) unomedical/medtronic minimed was informed about a patient death.The information from local administration comes after his/her family has received the ma-2017-02 / fa784 recall letter.The patient has different lots at his/her home so it is not possible to determine if the lot used at that date was the one impacted or not.No further information provided at this time.

Manufacturer Narrative

On 02/01/2018 - the reference samples were visually inspected and tested for flow and leak.All test results were within specifications.Based on the investigation and test results, the claimed failure can not be confirmed.If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.

Event Description

(b)(4).This event took place in (b)(6).Via an email from (b)(6) hospital unomedical/medtronic minimed was informed about a patient death.The information from local administration comes after his/her family has received the ma-2017-02 / fa784 recall letter.The patient has different lots at his/her home, so it is not possible to determine if the lot used at that date was the one impacted or not.No further information provided.

• Brand Name: SILHOUETTE PARADIGM
• Type of Device: COMFORT SHORT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320 ; 548167000
• MDR Report Key: 7163224
• MDR Text Key: 96329761
• Report Number: 8021545-2018-00001
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2021
• Device Model Number: MMT-381
• Device Lot Number: 5158227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death