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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE

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UNOMEDICAL A/S SILHOUETTE Back to Search Results
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.
 
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Brand NameSILHOUETTE
Type of DeviceSILHOUETTE
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 Key7163313
MDR Text Key96337379
Report Number8021545-2018-00002
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
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 Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2021
Device Model NumberMMT-369
Device Lot Number5151817
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2017
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 Treatment Data
Date Received: 01/04/2018 Patient Sequence Number: 1
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