MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM; OMP

Model Number WNDARM

Device Problems Break (1069); Device Fell (4014)

Patient Problems Bruise/Contusion (1754); Limb Fracture (4518); Swelling/ Edema (4577)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged bone fracture, swelling and bruising are related to activ.A.C.¿ ion progress¿ remote therapy monitoring system.Kci has made multiple unsuccessful attempts to obtain additional clinical identification information.A bone fracture has not been confirmed, and it was reported that no medical or surgical intervention was performed.Device labeling, available in print and online, states: keep the therapy unit in the upright position.Keep the therapy unit in the carrying case when in use.Keel the touch screen facing up if the therapy unit is laid on a level surface such as a table.Use the adjustable strap to wear the carrying case over your shoulder.You can also wear the carrying case on your belt.Make sure the case buckles are securely snapped together (if equipped).Do not wrap the carrying case strap, power cord or dressing tubing around neck.

Event Description

On 07-oct-2020, the following information was reported to kci by the patient: the activ.A.C.¿ ion progress¿ remote therapy monitoring system carrying case strap reportedly broke.The activ.A.C.¿ ion progress¿ remote therapy monitoring system subsequently fell and allegedly broke his toe.On 12-oct-2020, the following information was reported to kci by the patient: the carrying case has been discarded.The patient confirmed the activ.A.C.¿ ion progress¿ remote therapy monitoring system was working fine and continued to use the activ.A.C.¿ ion progress¿ remote therapy monitoring system.On 03-nov-2020, the following information was reported to kci by patient's family member: the patient's toe was allegedly swollen and bruised.No medical or surgical intervention was required.No additional has been provided.The carrying case was discarded; therefore, an evaluation could not be performed.

• Brand Name: ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; 6203 farinon drive; san antonio TX 78249
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 10802090
• MDR Text Key: 215075782
• Report Number: 3009897021-2020-01006
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDARM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• 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): Disability
• Patient Age: 46 YR