MAUDE Adverse Event Report: ALOE VESTA PROTECTIVE OINTMENT (AVPO); NONE

Device Problem Increased Sensitivity (2535)

Patient Problems Increased Sensitivity (2065); Urinary Tract Infection (2120); Fungal Infection (2419)

Event Date 06/06/2014

Event Type  Injury  

Event Description

It is reported that three (3) cases of pediatric end-users in pediatric intensive care unit (picu) with a foley catheter in place developed candid infection of the urine after the use of aloe vests protective ointment to the perianal area.It is further reported that two (2) more developed unspecified bacterial infection in urine while catheter in place.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.Then nurse has been contacted via voicemail to gather further info regarding these cases.The territory manager (tm) is involved in the case and is assisting convatec to ascertain additional info.No additional pt/event details have been provided to date.A return sample for eval is not expected.Should additional info become available, a follow-up report will be submitted.Please note: there were three (3) picu pts affected; therefore, a separate fda 3500a form has been generated to address the other two (2) cases reported under pt identifier (s): 355034 and 355855.Reported to the fda on july 1, 2014.(b)(6).Note: the actual date of event is unk, so the date used was the date convatec became aware.Convatec will continue to track and monitor such complaints according to convatec inc's.Complaint handling and capa procedures.

• Brand Name: ALOE VESTA PROTECTIVE OINTMENT (AVPO)
• Type of Device: NONE
• Manufacturer Contact: matthew walenciak, associate dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3975188
• MDR Text Key: 21239318
• Report Number: 1049092-2014-00259
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Other Device ID Number: UPC 76845510839
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention