MAUDE Adverse Event Report: SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK VISION

Model Number 271590

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).

• Brand Name: TUMARK VISION
• Type of Device: TUMARK VISION
• Manufacturer (Section D): SOMATEX MEDICAL TECHNOLOGIES GMBH; hohenzollerndamm 150/151; berlin, 14199 ; GM 14199
• MDR Report Key: 9380836
• MDR Text Key: 168573853
• Report Number: 1000408433-2019-00001
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 04250195607836
• UDI-Public: 04250195607836
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/22/2019,11/21/2019

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 271590
• Device Catalogue Number: 271590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/22/2019
• Date Report to Manufacturer: 08/22/2019
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 11/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial