MAUDE Adverse Event Report: CONVATEC, INC. ESTEEM SYNERGY® STOMAHESIVE® SKIN BARRIER; PROTECTOR, OSTOMY

Model Number 405458

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Patient height: 66 inches.Reported to the fda on october 13, 2015.(b)(4).

Event Description

It was reported the end user developed a circular peristomal rash under her skin barrier immediately following her ostomy surgery approximately 6 years ago.The rash has reportedly "come and gone in the level of severity over the years." the end user has been examined by both her physician and dermatologist.Treatments have included betamethasone, antifungal cream (nystatin), and desoximetasone; with the most noticeable improvement seen with the use of desoximetasone.In addition, the end user was encouraged to use an alternative adhesive remover.No further information was provided.

• Brand Name: ESTEEM SYNERGY® STOMAHESIVE® SKIN BARRIER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5150350
• MDR Text Key: 28306272
• Report Number: 1049092-2015-00597
• Device Sequence Number: 1
• Product Code: EXE
• 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: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 405458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Weight: 65