MAUDE Adverse Event Report: COVALON TECHNOLOGIES LTD. AQUAGUARD DRESSING; TAPE AND BANDAGE, ADHESIVE

Device Problem Leak/Splash (1354)

Patient Problem Itching Sensation (1943)

Event Type  Injury  

Event Description

Patient's father stated that water is still leaking through aquaguards when patient is showering causing itchiness and affecting the longevity of subcutaneous, site.Father did not report lot/expiration information, patient has more aquaguards on hand, item not available for return.No other information or dares known.Did the patient have a backup supply they we're able to switch to? yes; if yes, was the patient able to successfully continue their infusion? yes; is the infusion life-sustaining? yes; what is the outcome of the event? resolve? ongoing? resolved.Sending alternative product barrier hydroseal.Reported to (b)(6) by patient/caregiver.

• Brand Name: AQUAGUARD DRESSING
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): COVALON TECHNOLOGIES LTD.
• MDR Report Key: 10843492
• MDR Text Key: 216883289
• Report Number: MW5097880
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1