MAUDE Adverse Event Report: CONVATEC INC. NATURE DURAHESIVE MOLDABLE CONVEX SKIN BARRI; PROTECTOR, OSTOMY

Model Number 404593

Device Problem Leak/Splash (1354)

Patient Problems Cellulitis (1768); Erythema (1840)

Event Date 01/19/2015

Event Type  Injury  

Event Description

The end user reported she developed redness under the mass and tape collar of the skin barrier.The redness extended beyond the barrier and down to her groin.As a result of the redness, the patient was unable to establish a proper "seal" and the patient noted stool under her skin barrier on her abdomen and groin.The patient presented to the hospital and was admitted and treated for cellulitis of the abdomen.During her hospitalization, she was treated with intravenous antibiotics.She was prescribed an oral antibiotic and fluconazole powder to be applied to her peristomal skin.Shortly after discharge, the patient was diagnosed with oral thrush.Details regarding the treatment rendered for the patient's thrush were not provided.No further patient complications were reported.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No further information was available at the time of report.Additional patient and been requested.Should additional information become available, a follow-up report will be submitted.

• Brand Name: NATURE DURAHESIVE MOLDABLE CONVEX SKIN BARRI
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matther walenciak ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4486704
• MDR Text Key: 21338369
• Report Number: 1049092-2015-00079
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 404593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2015
• 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
• Patient Sequence Number: 1
• Treatment: SYNTHROID; NARCO; ZOCOR; DYAZIDE; OXYCONTIN; LOVENOX; PREDNISONE
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 68