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U.S. Department of Health and Human Services

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

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KINETIC CONCEPTS, INC. SNAP¿ THERAPY SYSTEM OKO Back to Search Results
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.
 
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Brand NameSNAP¿ THERAPY SYSTEM
Type of DeviceOKO
Manufacturer (Section D)
KINETIC CONCEPTS, INC.
san antonio TX
Manufacturer Contact
steven jackson
6203 farinon drive
san antonio, TX 
MDR Report Key7561605
MDR Text Key109834381
Report Number3009897021-2018-00053
Device Sequence Number1
Product Code OKO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K132080
Number of Events Reported1
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 Received06/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWNDSNP
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 Received05/03/2018
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
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