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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK VISION

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SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK VISION Back to Search Results
Model Number 271590
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 08/16/2019
Event Type  Injury  
Manufacturer Narrative
The clip was applied on (b)(6) 2019. On (b)(6) 2019, the patient was at a check-up appointment, when no abnormalies were detected. Thus, the clip was in the patient's body for 1 month without any irritation being detected. Furthermore, the patient never did an allergy test to prove that she is allergic to nickel. It is also not clear, what caused the abscess. Arising from this information, it is questionable, whether the event could be a reaction to the clip at all. It is stated in the instruction for use that the clip is made of a nickel titanium alloy. Furthermore, the following contraindication is defined in the instruction for use: "the use of the tumark vision system is contraindicated in patients who suffer from a severe nickel allergy. " in case that the patient is really allergic to nickel, the contraindication was not considered by the doctor. The doctor states, that the clip marker may not be responsible for the abscess and that a proof for the dependency between the marker and the abscess is hardly to deliver. She assumes that, arising from the skin irritation in combination with the chemotherapy, the patient definitely scratched herself very often, and hence, the patient may have fostered the developement of the abscess by herself.
 
Event Description
Suspicion of allergic reaction to nickel resulting in an abscess. Application of the product against the specified contraindication (marker consists partially of nickel).
 
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Brand NameTUMARK VISION
Type of DeviceTUMARK VISION
Manufacturer (Section D)
SOMATEX MEDICAL TECHNOLOGIES GMBH
hohenzollerndamm 150/151
berlin, 14199
GM 14199
MDR Report Key9380836
MDR Text Key168573853
Report Number1000408433-2019-00001
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K180443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 08/22/2019,11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number271590
Device Catalogue Number271590
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/22/2019
Event Location No Information
Date Report to Manufacturer08/22/2019
Date Manufacturer Received08/22/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 11/27/2019 Patient Sequence Number: 1
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