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Model Number WNDSNP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Injury (2348); Tissue Breakdown (2681)
Event Date 06/18/2019
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, it cannot be determined that the alleged maceration, slough and blistering are related to snap¿ 125mmhg therapy cartridge. 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) 2019, the following information was provided to kci by the physician: the patient allegedly experienced a technical issue with snap¿ therapy, and the patient experienced wound maceration, periwound blistering, "sloughy" wound bed with a "bad wound outcome. " on 26-jun-2019, the following information was provided to kci by the physician: on (b)(6) 2019, snap¿ therapy system was applied. On (b)(6) 2019, the patient experienced a lot of drainage from the wound, and the dressing reportedly did not adhere. The snap¿ therapy system allegedly had not indicated that a technical issue occurred. Upon complete dressing removal, the snap¿ therapy system allegedly did not indicate any sign of leakage. The physician noted that the due to the volume of exudate, the patient experienced maceration and periwound blisters. The patient subsequently underwent a drainage of the blister and a debridement. The physician reported that patient has peripheral vascular disease and was concerned the wound "might deteriorate" but confirmed the wound healed. The snap¿ 125mmhg therapy cartridge was not returned, therefore a device evaluation could not be performed. A device history review of snap¿ 125mmhg therapy cartridge lot number 5549875v001 determined that no nonconformances were identified nor deviations used during the manufacture of this lot. All end release testing of product and packaging met specifications. The snap¿ dressing lot number was not provided, therefore, a device history review could not be performed.
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Type of DeviceOKO
Manufacturer (Section D)
san antonio TX 78249
Manufacturer Contact
steven jackson
6203 farinon drive
san antonio, TX 78249
MDR Report Key8797841
MDR Text Key151293665
Report Number3009897021-2019-00081
Device Sequence Number1
Product Code OKO
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2020
Device Model NumberWNDSNP
Device Lot Number5549875V001
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 Received06/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2018
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: 07/17/2019 Patient Sequence Number: 1