MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. SNAP¿ THERAPY SYSTEM OKO

Model Number WNDSNP

Device Problem Insufficient Information (3190)

Patient Problem Necrosis (1971)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged worsened wound and maceration required medical or surgical intervention. There have been several attempts made to gather additional clinical information, but there has been no response. Device labeling, available in print and online, states: if a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance/expertise of a specialist: check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day). If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation. Clean wound more thoroughly during dressing changes. Evaluate for signs and symptoms of infection and, if present, treat accordingly. Change dressing often, ensuring that it is being changed at least every 48 hours. Examine the wound and debride as necessary. Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.

Event Description

On (b)(6) 2018, the following information was reported to kci by the customer: after the first dressing change post snap¿ therapy system placement on the patient's finger, the wound allegedly appeared worsened and was macerated. The secure ring allegedly "seemed melted. " no additional information is available. A lot number was not provided for the snap¿ therapy system therefore a device history review could not be performed.

• Brand Name: SNAP¿ THERAPY SYSTEM
• Type of Device: OKO
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX
• MDR Report Key: 7561605
• MDR Text Key: 109834381
• Report Number: 3009897021-2018-00053
• Device Sequence Number: 1
• Product Code: OKO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: WNDSNP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/01/2018 Patient Sequence Number: 1