MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE

Model Number	MMT-369
Medical Device Problem Code	Missing Value Reason (3192)
Health Effect - Clinical Code	Brain Injury (2219)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SILHOUETTE
• Manufacturer (Section D): UNOMEDICAL A/S; aaholvej 1-3; osted; lejre, 4320 ; DA 4320
• MDR Report Key: 7163313
• Report Number: 8021545-2018-00002
• Device Sequence Number: 1903113
• Product Code: FPA
• UDI-Device Identifier: 05705244005136
• UDI-Public: 05705244005136
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 01/04/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Model Number: MMT-369
• Device Lot Number: 5151817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening