MAUDE Adverse Event Report: INFINITE BIOMEDICAL TECHNOLOGIES LLC GLIDE; CUTANEOUS ELECTRODE

Model Number	91000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Infinite biomedical technologies is submitting the information to comply by 21 cfr 803.This report is based on the information received by infinite biomedical technologies llc (refered to as ibt hereafter), which the company may have not been able to fully investigate or verify prior to the date the report was required by the fda.Ibt has made reasonable efforts to obtain more complete information and has provided as much relevant information as available to the company as of the submission date of this report.D4: the device does not have an expiration date.H4: component code: there was no issue found with the device.There is no appropriate term code available.Following are the sections that are missing information when the report was submitted.Infinite biomedical technologies llc, is currently working on this and will send out an update report once received.A1 - a6: patient information.B3: date of the event.
Event or Problem Description
It was reported by the prosthetist that the patient was feeling uncomfortably warm on the distal end of the prosthesis.Prosthetist asked the patient to remove the prosthesis immediately as a precaution.The prosthetists also checked the prosthesis if they felt uncomfortably warm, but they did not feel the issue the patient mentioned.There was no patient injury involved in the case.
Additional Manufacturer Narrative
Infinite biomedical technologies is submitting the information to comply by 21 cfr 803.This report is based on the information received by infinite biomedical technologies llc (refered to as ibt hereafter), which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Ibt has made reasonable efforts to obtain more complete information and has provided as much relevant information as available to the company as of the submission date of this report.All the missing information from initial report submitted on 03/07/2025, has been added to this report.

• Brand Name: GLIDE
• Common Device Name: CUTANEOUS ELECTRODE
• Manufacturer (Section D): INFINITE BIOMEDICAL TECHNOLOGIES LLC; 8 market place; suite 500; baltimore MD 21202 4264
• Manufacturer (Section G): INFINITE BIOMEDICAL TECHNOLOGIES LLC; 8 market place; suite 500; baltimore MD 21202 4264
• Manufacturer Contact: rahul kaliki ; 8 market place; suite 500; baltimore, MD 21202-4264 ; 4434517175
• MDR Report Key: 21549641
• Report Number: 3004426795-2025-00001
• Device Sequence Number: 4420164
• Product Code: GXY
• UDI-Device Identifier: 00850004850619
• UDI-Public: 00850004850619
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K240884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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: Lay User/Patient
• Device Model Number: 91000
• Device Catalogue Number: 91000-GL-A
• Device Lot Number: 00001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TASKA GEN2.
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White