MAUDE Adverse Event Report: GCE, S.R.O. MEDITEC

Model Number	0721109US
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The box label has the wrong final product number (ref).There was completely correct marking on the medical device.
Additional Manufacturer Narrative
There was completely correct marking on the medical device.The box label includes the wrong final product number (ref).The whole delivery was isolated and relabelled by correct box label before release to the following distribution.

• Brand Name: MEDITEC
• Common Device Name: MEDITEC
• Manufacturer (Section D): GCE, S.R.O.; zizkova; 381; chotebor, 38301 ; EZ 38301
• Manufacturer Contact: romana holubcová ; zizkova; 381; chotebor, 58301 ; EZ 58301
• MDR Report Key: 19227588
• Report Number: 3003207908-2024-00001
• Device Sequence Number: 6882489
• Product Code: CAN
• UDI-Device Identifier: 08592346818088
• UDI-Public: 08592346818088
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 0721109US
• Device Catalogue Number: 0721109US
• Device Lot Number: 0000226073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown