MAUDE Adverse Event Report: CONVATEC INC ALLKARE PROTECTIVE BARRIER WIPE; PROTECTOR, OSTOMY

Lot Number 11339A L3

Device Problems Inadequate Instructions for Healthcare Professional (1319); Off-Label Use (1494)

Patient Problems Burning Sensation (2146); Chemical Exposure (2570)

Event Date 10/09/2014

Event Type  No Answer Provided  

Event Description

Patient was asked for a urine sample.Given specimen cup and wipe.As soon as patient cleaned herself she began to burn severely.Then labia and fingers stuck together.Patient and nurse pulled package from trash and discovered nurse had given her a skin barrier prep packet.Packaging very similar in size and color.Both are blue aqua and white.

• Brand Name: ALLKARE PROTECTIVE BARRIER WIPE
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american ave; greensboro, NC 27409
• MDR Report Key: 4302695
• MDR Text Key: 5059354
• Report Number: 4302695
• Device Sequence Number: 2
• Product Code: EXE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/15/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Invalid Data
• Device Lot Number: 11339A L3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2014
• Patient Sequence Number: 1