MAUDE Adverse Event Report: INFINITE BIOMEDICAL TECHNOLOGIES LLC FLEXCELL MINI; PROSTHETIC BATTERY SYSTEM

Model Number 3027200

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Patient's prosthesis stopped working and had a burnt smell.When opened, it was observed that the components near the flexcell system were damaged.During the event, no injuries were reported.

Manufacturer Narrative

The details on patient information are pending and will be provided once the practitioner responds to manufacturer.Date of event: - the exact date of the event is not known and the clinician informed the manufacturer that they can't dig up the date of event.Therefore, manufacturer (ibt) is unable to provide the date of the event.Relevant tests/laboratory data: the parts were disposed by the clinician.Therefore, no further investigation can be performed on the affected parts.Concomitant medical products and therapy dates: the details on components used in prosthesis are pending and will be provided once the practitioner responds to the manufacturer.If remedial action initiated: no remedial action has been taken by the manufacturer as the clinician is not very responsive.

Manufacturer Narrative

The manufacturer (infinite biomedical technologies llc, here after referred to as ibt) tried to reaching out to the clinician but he is not very responsive.Ibt has setup a meeting with the distributors to gain more information on this issue.A follow-up report will be sent based on the information obtained from the distributor.

Manufacturer Narrative

Infinite biomedical technologies (hereafter referred to as ibt) reached out to the distributor to obtain more information on this issue.Ibt had requested following information 1.Section a: patient information.2.Section b3: date of event.3.Section d - suspect medical device, block 10 - concomitant medical products and therapy dates will not be provided due to confidentiality rules at the hospital.Distributor informed that the above requested information cannot be provided due to confidentiality rules at the hospital.Therefore ibt cannot provide any further detail on this report.

• Brand Name: FLEXCELL MINI
• Type of Device: PROSTHETIC BATTERY SYSTEM
• 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: 15295457
• MDR Text Key: 305350911
• Report Number: 3004426795-2022-00005
• Device Sequence Number: 1
• Product Code: IQZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3027200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1