MAUDE Adverse Event Report: CONVATEC INC. NATURA 2 PC STOMAHESIVE WAFER W/FLEX COLLAR; PROTECTOR, OSTOMY

Model Number 125271

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Itching Sensation (1943)

Event Date 12/13/2013

Event Type  Injury  

Event Description

End-user reported redness and itching located under wafer and now extends to any skin folds on abdomen.It is reported that this issue began seven (7) months ago.

Manufacturer Narrative

Based on the available information, this event is deemed a serious injury.It is reported end-user was prescribed nystatin by wound ostomy continence nurse (wocn) without improvement.The correct application technique of nystatin power under wafer and the use of miconazole powder applied to skin fold areas of abdomen were discussed with end-user.Lastly, it is reported that end-user does not have the box or lot number available for evaluation.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information becomes available, a follow-up report will be submitted.Note: the actual date of event) is unknown, so the date used was the date convatec became aware.

• Brand Name: NATURA 2 PC STOMAHESIVE WAFER W/FLEX COLLAR
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: mary szaro, associate dir. ; 200 headquarters park drive; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3594820
• MDR Text Key: 4093569
• Report Number: 1049092-2014-00033
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 125271
• Device Catalogue Number: 125271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2013
• 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
• Patient Weight: 91