MAUDE Adverse Event Report: CRAWFORD HEALTHCARE LTD KERRALITE COOL¿ BORDER DRESSING; NAC

Model Number KRRLCB

Device Problem Insufficient Information (3190)

Patient Problems Skin Irritation (2076); Impaired Healing (2378); Skin Inflammation (2443)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact occurrence date for the four patient's is unknown.The tissue viability nurse stated it has occurred within the last four to six weeks.Device identifier was not provided.Based on the information provided, it cannot be determined that the alleged inflammation, hypergranulation, delay in wound healing are related to the kerralite cool¿ border dressing.It is unknown if and what medical or surgical intervention was required.

Event Description

On 03-mar-2020, the following information was reported to kci by the tissue viability nurse: the tissue viability nurse was concerned regarding several unusual responses on skin tears seen within the last four to six weeks.There was significant hypergranulation and inflammatory responses and delayed healing seen with four patients allegedly involving the kerralite cool¿ border dressing.No additional information was provided.The kerralite cool¿ border dressing lot number is not available and the product was discarded, therefore, a device history review and a device evaluation could not be performed.

Manufacturer Narrative

Mdr 3004051837-2020-00001 sent on 02-apr-2020 provided the following: b5 describe event or problem: on (b)(6) 2020, the following information was reported to kci by the tissue viability nurse: the tissue viability nurse was concerned regarding several unusual responses on skin tears seen within the last four to six weeks.There was significant hypergranulation and inflammatory responses and delayed healing seen with four patients allegedly involving the kerralite cool¿ border dressing.No additional information was provided.The correction is indicated in b5.Information was reported to kci/crawford on various dates and specifics regarding inflammatory responses were provided.Mdr reference 3004051837-2020-00002 included to specify report for the patient with specific clinical information and photos.Based on the additional information received on 16-mar-2020 and the corrections, kci/crawfords's assessment remains the same; it cannot be determined that the alleged inflammation, hypergranulation, minor bleeding, and delay in wound healing are related to the kerralite cool¿ border dressing.The facility report noted the type of injury as minor.The bleeding was assessed as minor and deemed not reportable.Kci/crawford has made multiple unsuccessful attempts to obtain additional clinical and device information.Device labeling, available in print and online, instructs the user to check the wound regularly.The dressing should be changed as often as the condition of the wound dictates.Labeling precautions warn the user to not use on patients with a known sensitivity to hydrogel (allergic reaction).

Event Description

On (b)(6) 2020, the following information was reported to kci/crawford by the tissue viability nurse: the tissue viability nurse (tvn) was concerned regarding the inflammatory and over granulation response to a patient's upper body skin tear allegedly involving the kerralite cool¿ border dressing.On 06-mar-2020, the facility report was provided to kci/crawford by the tissue viability nurse: the report noted several unusual responses to the dressing applied to upper body skin tears causing significant hypergranulation / inflammatory response and delayed healing with approximately five patients within the last four to six weeks.Type of injury was noted as minor.On 10-mar-2020, the tissue viability nurse provided photos and specific patient information for one of the five patients.Mdr 3004051837-2020-00002 addresses the one patient with photos and specific clinical information.On 16-mar-2020, the following information was reported to kci/crawford by the tissue viability nurse: the concern was raised following bleeding [assessed as minor] and over-granulation response following the use of kerralite cool¿ border dressing.

• Brand Name: KERRALITE COOL¿ BORDER DRESSING
• Type of Device: NAC
• Manufacturer (Section D): CRAWFORD HEALTHCARE LTD; king edward court; king edward road; knutsford, wa16 0be ; UK
• MDR Report Key: 9919052
• MDR Text Key: 196937937
• Report Number: 3004051837-2020-00001
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KRRLCB
• Device Catalogue Number: CWL1008
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other