MAUDE Adverse Event Report: C2DX, INC. C2DX; T/PUMP PROFESSIONAL

Model Number NOT KNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 08/03/2022

Event Type  Injury  

Event Description

(b)(6) called and spoke to a c2dx representative about the maintenance of the t/pump device.During the conversation with the c2dx rep, (b)(6) mentioned that "these burn patients all the time." (b)(6) was not willing to give c2dx more detail at the time of the complaint.During follow up investigation, c2dx discovered that there was a burn incident earlier this year when a patient was left on their back for a long period of time without having their skin checked or monitored.After multiple attempts to connect with tabitha inc., additional details about the incident were not provided to c2dx, and tabitha inc.Did not report this event to c2dx at the time it occurred.(b)(6) confirmed that the instructions for use were not followed and that is the patient suffered a burn.

Manufacturer Narrative

Manufacturer was not able to obtain the device or speak to other facility representatives at tabitha inc.Facility confirmed that the instructions for use were not followed during use of the device.

• Brand Name: C2DX
• Type of Device: T/PUMP PROFESSIONAL
• Manufacturer (Section D): C2DX, INC.; 555 e. eliza street; ste a; schoolcraft MI 49087
• Manufacturer Contact: kerri rosenbaum ; 555 e. eliza street; ste a; schoolcraft, MI 49087 ; 8889022239
• MDR Report Key: 15349512
• MDR Text Key: 299181549
• Report Number: 3015489752-2022-00002
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: NOT KNOWN
• Device Catalogue Number: NOT KNOWN
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention