MAUDE Adverse Event Report: CRAWFORD HEALTHCARE LTD KERRAFOAM; KERRAFOAM GENTLE BORDER LARGE SACRUM

Model Number CWL1040

Device Problem Use of Device Problem (1670)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/12/2016

Event Type  Injury  

Event Description

Upon removal of the kerrafoam dressing for routine skin check customer described a medical adhesive related skin injury around the edge of the dressing adhesive area.

• Brand Name: KERRAFOAM
• Type of Device: KERRAFOAM GENTLE BORDER LARGE SACRUM
• Manufacturer (Section D): CRAWFORD HEALTHCARE LTD; king edward court; king edward road; knutsford, WA16 0BE; UK WA16 0BE
• Manufacturer (Section G): CRAWFORD HEALTHCARE LTD; king edward court; king edward road; knutsford, WA16 0BE; UK WA16 0BE
• Manufacturer Contact: andrew jackson ; king edward court; king edward road; knutsford, WA16 -0BE ; UK WA16 0BE
• MDR Report Key: 8463670
• MDR Text Key: 140278359
• Report Number: 3004051837-2019-00005
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2016,03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: CWL1040
• Device Lot Number: 11501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/12/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2016
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR