MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE

Model Number MMT-369

Device Problem Missing Value Reason (3192)

Patient Problem Brain Injury (2219)

Event Type  Injury  

Manufacturer Narrative

The reference samples were visually inspected and tested for flow and leak.All test results were within specifications.The claimed failure cannot be confirmed.An investigation has been performed based on the customer complaint description and the reference samples from the same lot number.According to unomedical's traceability records, no relevant deviations were found.If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.

Event Description

(b)(4).The patient called in reporting that experienced a traumatic brain injury and was in the icu due to this event, there was no information of what could have caused this event, no self malfunction or failure is mentioned in the complaint, also no symptoms of dka or low bg levels that could relate to patients brain injury.No further information available.

• Brand Name: SILHOUETTE
• Type of Device: SILHOUETTE
• Manufacturer (Section D): UNOMEDICAL A/S; aaholvej 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 ; 558167000
• MDR Report Key: 7163313
• MDR Text Key: 96337379
• Report Number: 8021545-2018-00002
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244005136
• UDI-Public: 05705244005136
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Model Number: MMT-369
• Device Lot Number: 5151817
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening