MAUDE Adverse Event Report: CONVATEC INC. NATURA 2 PC - DURAHESIVE CONVEX MOLDABLE WAFER; PROTECTOR, OSTOMY

Model Number 404593

Device Problem Leak/Splash (1354)

Patient Problem Skin Inflammation (2443)

Event Date 06/18/2014

Event Type  Injury  

Event Description

It is reported that the patient, who resides in a nursing home and is being administered nutrition via a gastrostomy tube (g tube), presented with redness to the skin located under mass and tape collar related to leakage from the ostomy pouch.It is further reported that the leakage is possibly related to the pouch being rolled up underneath patient when repositioned from side to side by the nursing staff.Lastly, treatment for this issue was provided with nystatin or stomahesive powder, and cavilon protective barrier spray to skin as needed.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Further clarification in regards to whether nystatin powder used was an over the counter (otc) or a prescription medication was not available.In addition, product wear time is unknown, and patient plans to follow-up with local would nurse soon to discuss alternate products.Lastly, it is reported that patient has tried a high output pouch in past but declines to use it now.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.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: NATURA 2 PC - DURAHESIVE CONVEX MOLDABLE WAFER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, interim assoc ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3950990
• MDR Text Key: 4602096
• Report Number: 1049092-2014-00293
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K855018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 404593
• Device Catalogue Number: 404593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention